Feeds:
Posts
Comments

Archive for the ‘Mitral Valve: Repair and Replacement’ Category

Hadassah Opens Israel’s First Heart Valve Disease Clinic

Reporter: Aviva Lev-Ari, PhD, RN

 

WEDNESDAY, NOV 30 2016

“Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves.”

The Hadassah Medical Organization has opened Israel’s first Heart Valve Disease Clinic, which is geared toward detecting and treating the most complicated cases of heart valve disease–a growing problem in an aging population.

Until recently, the default treatment for valve disease has been open heart surgery to replace the damaged valve or valves. Currently, these invasive procedures are often superseded by less invasive cardiac catheterizations. In any case, however, efficiently treating valve disease and minimizing life-threatening risk factors such as heart attack remains an ongoing struggle for cardiovascular specialists.

As Prof. Ronen Beeri, head of Hadassah’s Cardiovascular Research Center, explains: “A ‘cardio team’ is needed to treat a patient suffering from heart valve disease. The time from referral to our Heart Institute to receive treatment from the relevant specialist can sometimes take months. Generally, patients with complex issues cannot afford to wait that long. The multidisciplinary cardio team solution at our new Clinic will help streamline the process so that a patient will receive all the necessary echocardiograms and other exams needed to diagnose and begin treatment within a week’s time.”

SOURCE

http://www.hadassah.org/news-stories/heart-valve-disease.html

Read Full Post »

The presence of any Valvular Heart Disease (VHD) did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with Warfarin

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 10/22/2018

Dabigatran (Pradaxa) was no better than aspirin for prevention of recurrent stroke among patients with an embolic stroke of undetermined source in the RE-SPECT ESUS trial reported at the World Stroke Congress.

 

Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® equates to over 9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than ten years and is approved in over 100 countries.15
Currently approved indications for Pradaxa® are:16,17
  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and recurrent PE in adults
Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.18,19,20
REFERENCES

SOURCE

https://www.boehringer-ingelheim.com/press-release/Results-from-two-Pradaxa-trials-to-be-presented-at-WSC

 

 

Event Rate and Outcome Risk, With vs Without Valvular Heart Disease

Outcome Valvular heart disease, event rate/y, % No valvular heart disease, event rate/y, % HR (95% CI)* P
Stroke, systemic embolic event 1.61 1.41 1.09 (0.88–1.33) 0.43
Major bleeding 4.36 2.84 1.32 (1.16–1.33) <0.001
Intracranial hemorrhage 0.51 0.41 1.20 (0.83–1.74) 0.32
All-cause mortality 4.45 3.67 1.09 (0.96–1.23) 0.18
*Adjusted using propensity scores

ORIGINAL RESEARCH ARTICLE

Comparison of Dabigatran versus Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial

Michael D. Ezekowitz, Rangadham Nagarakanti, Herbert Noack, Martina Brueckmann, Claire Litherland, Mark Jacobs, Andreas Clemens,Paul A. Reilly, Stuart J. Connolly, Salim Yusuf and Lars Wallentin

 http://dx.doi.org/10.1161/CIRCULATIONAHA.115.020950

 

Results—There were 3950 patients with any VHD:

  • 3101 had mitral regurgitation,
  • 1179 tricuspid regurgitation,
  • 817 aortic regurgitations,
  • 471 aortic stenosis and
  • 193 mild mitral stenosis.

At baseline patients with any VHD had more

  • heart failure,
  • coronary disease,
  • renal impairment and
  • persistent atrial fibrillation.

Patients with any VHD had higher rates of

  • major bleeds (HR 1.32; 95% CI 1.16-1.5)

but similar

  • stroke or systemic embolism (SEE) rates (HR 1.09; 95% CI 0.88-1.33).

For D110 patients, major bleed rates were lower than warfarin (HR 0.73; 95% CI 0.56-0.95 with and HR 0.84; 95% CI 0.71-0.99 without VHD) and

For D150 similar to warfarin in patients with (HR 0.82; 95% CI 0.64-1.06) or without VHD (HR 0.98; 95% CI 0.83-1.15).

For D150 patients stroke/SEE rates were lower versus warfarin with (HR 0.59; 95% CI 0.37-0.93) and without VHD (HR 0.67; 95% CI 0.52-0.86) and similar to warfarin for D110 irrespective of presence of VHD (HR 0.97 CI 0.65-1.45 and 0.85 CI 0.70-1.10).

For intracranial bleeds and death rates for D150 and D110 were lower vs warfarin independent of presence of VHD.

Conclusions—The presence of any VHD did not influence the comparison of dabigatran with warfarin.

Clinical Trial Registration—URL: http://clinicaltrials.gov. Unique Identifier: NCT00262600.

SOURCES

http://circ.ahajournals.org/content/early/2016/08/05/CIRCULATIONAHA.115.020950

http://www.medscape.com/viewarticle/867482?nlid=108872_3866&src=WNL_mdplsfeat_160816_mscpedit_card&uac=93761AJ&spon=2&impID=1179558&faf=1

 

Read Full Post »

Clinical Trials for Transcatheter Mitral Valves Annulus Repairs and TAVR: CT Structural Software for Procedural Planning and Anatomical Assessments

Reporter: Aviva Lev-Ari, PhD, RN

 

 

VIEW VIDEO

http://www.dicardiology.com/videos/what-look-ct-structural-heart-planning-software/5027704022001?eid=333021707&bid=1497257

 

What to Look for in CT Structural Heart Planning Software

An interview with Jonathan Leipsic, M.D., FSCCT, chairman of the department of radiology, St. Paul’s Hospital, Vancouver, Canada, at the Society of Cardiovascular Computed Tomography (SCCT) 2016 meeting. Leipsic is heavily involved with the procedural planning and anatomical assessments for TAVR and clinical trials for new transcatheter mitral valves and annulus repairs. 

SOURCE

From: Diagnostic and Interventional Cardiology <mail@sgc-ecms.com>

Reply-To: <DoNotReply@sgc-ecms.com>

Date: Monday, August 15, 2016 at 11:20 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: VIDEO: What to Look for in CT Structural Heart Planning Software

Read Full Post »

ACC: Still No Benefit to CABG, Mitral Valve Fix Combo

Reporter: Aviva Lev-Ari, PhD, RN

 

 

 

 

(MedPage Today) — Endpoints at 2 years no better for combination procedure than at 1 year

Sourced through Scoop.it from: www.medpagetoday.com

See on Scoop.itCardiovascular and vascular imaging

View our Book

  • Cardiovascular Diseases, Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment. On Amazon.com since 12/24/2018

https://www.amazon.com/dp/B07MKHDBHF

 

Read Full Post »

Moderate Ischemic Mitral Regurgitation: Outcomes of Surgical Treatment during CABG vs CABG without Mitral Valve Repair

Curator: Aviva Lev-Ari, PhD, RN

 

Original Article

Michler RE et al. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med2016 Apr 3; [e-pub]. (http://dx.doi.org/10.1056/NEJMoa1602003)

– See more at: http://www.jwatch.org/na40963/2016/04/03/repairing-moderate-mitral-regurgitation-during-cabg-update#sthash.3wfUSvPm.dpuf

 

April 3, 2016

Repairing Moderate Mitral Regurgitation During CABG: An Update

 

Harlan M. Krumholz, MD, SM reviewing Michler RE et al. N Engl J Med 2016 Apr 3.

Two-year findings do not support widespread adoption of the combined procedure.

When the Cardiothoracic Surgical Trials Network randomized 301 patients with moderate mitral regurgitation to undergo coronary artery bypass grafting (CABG) alone or CABG plus mitral valve repair, the two groups had similar postsurgical ventricular dimensions, survival, and major adverse events at 1 year. However, the combined-procedure group had a significantly lower prevalence of moderate-to-severe mitral regurgitation — but longer postsurgical hospital stays and higher incidences of postoperative supraventricular arrhythmias and serious neurologic events (NEJM JW Cardiol Jan 2015 and N Engl J Med 2014; 371:2178).

We now have the 2-year findings.

  • The postsurgical left-ventricular end-systolic volume index was again similar between the two groups.
  • Two-year mortality was slightly, but not significantly, higher with CABG alone than with the combined procedure (10.6% vs. 10.0%)
  • CABG-alone group had a significantly higher incidence of moderate-to-severe mitral regurgitation (32% vs. 11%).
  • The two groups had similar rates of hospital readmission and
  • The two groups had similar major adverse events,
  • Most quality-of-life scores were similar between the two groups.

except that

  • serious neurologic events and supra-ventricular arrhythmias were significantly more common with the combined procedure.

 

SOURCES

Michler RE et al. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med2016 Apr 3; [e-pub]. (http://dx.doi.org/10.1056/NEJMoa1602003)

http://www.jwatch.org/na40963/2016/04/03/repairing-moderate-mitral-regurgitation-during-cabg-update#sthash.3wfUSvPm.dpuf

http://www.jwatch.org/na40963/2016/04/03/repairing-moderate-mitral-regurgitation-during-cabg-update

 

Other related articles published in this Open Access Online Scientific Journal Include the following:

Articles on Heart Failure N=6

http://pharmaceuticalintelligence.com/?s=Heart+Failure

Articles on coronary artery bypass graft CABG N=36

http://pharmaceuticalintelligence.com/?s=CABG

Articles on Pharmacotherapy of Cardiovascular Diseases N=296

http://pharmaceuticalintelligence.com/?s=Pharmacotherapy+of+Cardiovascular+Disease

Articles on Mitral Valve Repair or Replacement N = 47

Read Full Post »

FDA approves 4th-gen MitraClip for TMVR 

Updated Issue with Delivery System Deployment Process: MitraClip Clip Recalled by Abbott Vascular

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 4/26/2022

VIDEO: MitraClip vs. surgical mitral valve replacement

Joanna Chikwe, MD, founding chair of the Department of Cardiac Surgery and the Irina and George Schaeffer Distinguished Chair in Cardiac Surgery, Cedars-Sinai Hospital, Los Angeles, led a panel discussion comparing transcatheter edge-to-edge repair (TEER) to mitral valve surgery for primary mitral regurgitation. At the American College of Cardiology (ACC) 2022 session, Chikwe steered the discussion on the latest evidence in valvular disease, surgical repair and structural heart repair for primary mitral regurgitation.

Related TEER and Mitral Valve Content:

New risk score predicts mortality after TEER

Both younger and elderly heart failure patients benefit from TEER

Cutting edge findings shine new light on mitral valve surgery after failed TEER

New risk calculator detects TEER patients who may need to be readmitted for HF

TEER associated with ‘important and significant’ reductions in hospitalization rates

In-hospital stroke rates higher after TAVR than MitraClip procedures
SOURCE

https://www.cardiovascularbusiness.com/topics/structural-heart-disease/video-mitraclip-vs-surgical-mitral-valve-replacement?utm_source=newsletter&utm_medium=cvb_tavr

UPDATED on 11/21/2019

MitraClip Cases Often Involve Risky Pulmonary HTN

Intervention should be earlier in the disease course, study suggests

by Nicole Lou, Reporter, MedPage Today/CRTonline.org

As in the case of mitral valve surgery, there is a graded association between pulmonary hypertension and increased mortality following the MitraClip procedure, a registry study showed.

Higher invasive mean pulmonary arterial pressure (mPAP) at baseline was associated with greater likelihood of death and heart failure readmission 1 year after transcatheter mitral valve repair (P<0.001):

  • No pulmonary hypertension (mPAP <25 mm Hg): 27.8%
  • Mild pulmonary hypertension (mPAP 25-34 mm Hg): 32.4%
  • Moderate pulmonary hypertension (mPAP 35-44 mm Hg): 36.0%
  • Severe pulmonary hypertension (mPAP 45 mm Hg or above): 45.2%

The overall incidence of the composite outcome was 33.6% in a U.S. registry that showed most people going into valve repair with at least mild pulmonary hypertension, according to the report by Sammy Elmariah, MD, MPH, of Massachusetts General Hospital in Boston, and colleagues, published online in JAMA Cardiology.

After multivariable adjustment, pulmonary hypertension remained significantly associated with mortality (HR 1.05 per 5-mm Hg increase in mPAP, 95% CI 1.01-1.09) and heart failure hospitalization (HR 1.04 per 5-mm Hg increase in mPAP, 95% CI 1.01-1.07) after MitraClip placement.

The findings have implications for patient management, according to Elmariah’s team.

Primary Source

JAMA Cardiology

Source Reference: Al-Bawardy R, et al “Association of pulmonary hypertension with clinical outcomes of transcatheter mitral valve repair” JAMA Cardiol 2019; DOI: 10.1001/jamacardio.2019.4428.

SOURCE

https://www.medpagetoday.com/cardiology/pci/83475?xid=nl_mpt_DHE_2019-11-21

UPDATED on 7/17/2019

FDA approves 4th-gen MitraClip for TMVR

SOURCE

https://www.cardiovascularbusiness.com/topics/structural-congenital-heart-disease/fda-approves-4th-gen-mitraclip-tmvr?utm_source=newsletter&utm_medium=cvb_news

UPDATED on 9/20/2018

TCT: Second Chance for MitraClip in Functional Mitral Regurgitation?

COAPT takes the spotlight in San Diego

by Nicole Lou, Contributing Writer, MedPage Today

This article is a collaboration between MedPage Today® and:

 Medpage Today

SAN DIEGO — The highly-anticipated COAPT trial — examining cardiovascular outcomes in certain heart failure patients treated with the MitraClip device — will be a highlight of the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference, which turns 30 years old this year.

COAPT will be the MitraClip’s shot at redemption and features a similar patient population as the MITRA-FR trial, which showed no improvement over medical therapy alone for preventing hard outcomes in heart failure patients with secondary mitral regurgitation. MITRA-FR was recently presented at the European Society of Cardiology meeting.

SOURCE

https://www.medpagetoday.com/meetingcoverage/tct/75181?xid=nl_mpt_ACC_Reporter_2018-09-20&eun=g5099207d2r

MitraClip

Photo of MitraClip Clip Delivery System®

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm490774.htm

 

Device Use

The Abbott Vascular MitraClip Delivery System is intended to treat patients with degenerative mitral regurgitation (DMR) a condition involving a dysfunction of the heart’s mitral valve. The MitraClip Clip Delivery System is indicated for use in patients who have been determined to be at prohibitive risk for mitral valve surgery.

The delivery system has three parts: a delivery catheter; a steerable sleeve; and an implantable clip. The implantable clip is introduced into the left atrium of the heart through the steerable sleeve and the delivery catheter. The implantable clip is then positioned and closed between the leaflets that separate the left atrium and the left ventricle to reduce the reversed blood flow.

Reason for Recall

Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open heart surgery to retrieve the delivery system. Abbott Vascular is therefore recalling the MitraClip Delivery System to provide updated instructions and training for health care providers who use the device.

The use of affected products may cause serious adverse health consequences, including serious patient injury or death. Currently there are 3,534 devices on the market, with nine reports of this malfunction. There has been 1 death.

Who May be Affected

  • Health care providers implanting the MitraClip Clip Delivery System
  • All patients undergoing a mitral regurgitation procedure using the MitraClip Clip Delivery System

What to Do

On February 4, 2016, Abbott Vascular issued a safety notice to all physicians using the device instructing them to:

  • Carefully read the revised deployment sequence instructions
  • Participate in training with an Abbott Vascular representative
  • Share the information with other pertinent staff

Contact Information:

Customers can contact Abbott Vascular Customer Support at 1-800-227-9902.

Date Recall Initiated:

February 4, 2016

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online, by regular mail or by FAX.

 

SOURCES

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm490774.htm

Abbott Issues Voluntary Safety Notice on MitraClip® Delivery System Deployment Process

MitraClip Delivery System by Abbott: Safety Notice – Reinforcement of Proper Procedures to Operate and Deploy

Read Full Post »

UPDATED on 3/17/2019

https://www.medpagetoday.com/cardiology/prevention/78202?xid=nl_mpt_SRCardiology_2019-02-25&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CardioUpdate_022519&utm_term=NL_Spec_Cardiology_Update_Active

The Pascal transcatheter mitral valve repair system was approved for use in Europe, Edwards announced. (MassDevice) Level III echo training has been around for years but is now codified in a statement from the American College of Cardiology, the American Heart Association, and the American Society of Echocardiography.

Prospects for First-in-man Implantation of Transcatheter Mitral Valve by Direct Flow Medical

Reporter: Aviva Lev-Ari, PhD, RN

  • Market share for surgically implantable  devices 800,000 U.S. annually
  • Market share for Mitral Valve Repair an untapped 5-6M annually patient population 

SOURCE

From: Edward Hlozek <mind.and.associates.inc@gmail.com> on behalf of Edward Hlozek <ehlozek@valvecure.com>

Date: Thursday, March 3, 2016 at 12:55 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Re: Prospects for First-in-man Implantation of Transcatheter Mitral Valve by Direct Flow Medical | Leaders in Pharmaceutical Business Intelligence

VIEW IMAGES of the Procedure

Current Products at Direct Flow Medical

WATCH VIDEO

https://www.youtube.com/watch?v=HNZTJ_8I2f0

Published on Jul 23, 2013

Dr. Randy Martin and Corporate Vice President of Edwards Lifesciences, Don Bobo, discuss the current state of mitral valve disease in the U.S. and the need for additional education around mitral valve repair.

The AATS 2013 Mitral Conclave convened on May 2nd and 3rd, 2013, to bring the world’s leading figures in mitral valve disease together to discuss management guidelines, imaging, pathology, minimally invasive procedures, percutaneous approaches, surgical techniques, devices, and long-term results.

The 1,000+ attendees included leaders in the field of mitral valve surgery and physicians from more than 60 countries. The Mitral Foundation is proud to have sponsored this video series, “Thought Leaders” hosted by Dr. Randy Martin.

View the complete AATS 2013 Mitral Conclave webcast at http://www.aats.org/mitral/webcast
Learn more about the Mitral Foundation, including education and training opportunities, at http://www.mitralfoundation.org

Direct Flow Medical® Transcatheter Aortic Valve System

The Direct Flow Medical system is designed to treat aortic stenosis with minimal risk of aortic regurgitation, a significant clinical complication with current transcatheter aortic heart valve replacement (TAVR) systems. By reducing the risks of TAVR, the Direct Flow Medical system is designed to improve the long-term outcomes of patients undergoing this procedure.

The system’s unique design encompasses a distinctive metal-free valve frame and flexible, low-profile delivery system, which enables limitless repositionability and repeated assessment of full hemodynamic performance before final implantation.

SOURCE

http://directflowmedical.com/us/

NEWS | HEART VALVE REPAIR | FEBRUARY 18, 2016

Direct Flow Medical Unveils Transcatheter Mitral Valve

Company hopes to achieve first-in-man implantation in fourth quarter of 2016

Direct Flow Medical, transcatheter mitral valve, preclinical case

February 18, 2016 — Direct Flow Medical Inc. announced its transcatheter mitral valve (TMV) development program at the 2nd Annual Zurich Heart Team Mitral Valve meeting by featuring the Direct Flow Medical Transcatheter Mitral Valve in a preclinical case presentation.

The Direct Flow Medical Transcatheter Mitral Valve is built upon the conformable, repositionable and retrievable Direct Flow Medical Transcatheter Aortic Valve. The aortic valve has more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant and mortality. The mitral-specific valve design features low atrial profile, low ventricular projection, and unique conformable sealing and fixation rings for the complex mitral annulus.

Azeem Latib, M.D., San Raffaele Hospital, Milan, presented preclinical results demonstrating transapical implant feasibility. Latib noted, “The valve’s unique conformable ring design is ideally suited for the complex shape of the mitral annulus.” He said, “Implanting this valve was similar to implanting the Direct Flow Medical Transcatheter Aortic Valve as I had total procedural control and performed a full hemodynamic assessment prior to deployment.”

Direct Flow Medical President and CEO Dan Lemaitre said that much of the mitral valve’s preclinical testing is completed, and the company hopes to achieve a first-in-man implant objective in the fourth quarter of 2016.

For more information: www.directflowmedical.com

– See more at: http://www.dicardiology.com/content/direct-flow-medical-unveils-transcatheter-mitral-valve#sthash.WTb1EvYs.gc3onuP1.dpuf

Read Full Post »

Boston Scientific ($BSX) has obtained an exclusive $200 million option to acquire Israel’s MValve Technologies, maker of a transcatheter mitral valve replacement (TMVR) system for mitral regurgitation

Reporters: Gerard Loiseau and Aviva Lev-Ari, PhD, RN

Boston Scientific announces $200M option to purchase Israeli transcatheter mitral valve player

 

By Varun Saxena

Boston Scientific’s Lotus valve is implanted in the mitral valve using MValve’s docking system–Courtesy of Boston Scientific

Boston Scientific ($BSX) announced that it has obtained an exclusive $200 million option to acquire Israel’s MValve Technologies, maker of a transcatheter mitral valve replacement (TMVR) system for mitral regurgitation. Boston Scientific also said it is providing additional financing to the company in anticipation of a first in-human clinical trial. The bigwig has been financing MValve since 2012.

The official announcement of the option came just now, though Israeli newspaper paper Globes broke the news last year. Such a transaction would add to the $1 billion-plus spent by competitors Abbott ($ABT), Medtronic ($MDT) and Edwards ($EW) in recent months, as they place their bets on different companies in the hopes of winning the battle for transcatheter mitral valve dominance. The treatment paradigm is expected to someday become several multiples of the fast-growing market for transcatheter aortic valve replacements, estimated to be $2 billion at present.

MValve is developing a docking system for TMVR that works in conjunction with Boston Scientific’s Lotus Valve (currently used for TAVR, at least in Europe). That makes Boston Scientific’s approach distinct from those of its competitors, which are acquiring companies that make the actual implants as well as the associated delivery catheters. In general, delivery systems pose fewer clinical risks than the implants that they deliver, so Boston Scientific’s strategy could prove clever, assuming its Lotus Valve proves efficacious in the mitral valve too.

“The TMVR segment represents another significant growth opportunity as we continue to build our Structural Heart portfolio,” said Kevin Ballinger, senior vice president and president of Boston Scientific’s interventional cardiology unit, in a statement. “This round of financing will support the development of the MValve technology in anticipation of a first-in-human clinical trial, and we are pleased to be continuing our collaboration.”

In fact, MValve just announced the first implantation of the Lotus TAVR using its docking system. The procedure occurred in Bonn, Germany, on a 72-year-old with mitral valve disease and a failing surgical valve. Mitral valve surgery and other transcatheter therapies were not possible due to the patient’s challenging anatomy, heavy calcification, and failed prior treatments attempts, according to an MValve release, demonstrating how transcatheter technologies enable treatment in patients who otherwise lack options.

“The MValve docking device provides a secure platform within the mitral annulus, enabling the implantation of an approved transcatheter heart valve, such as the Lotus valve, in the native mitral position,” said Dr. Maurice Buchbinder, the founder of MValve, in a statement. “This procedure in many ways mimics the ‘Valve-in-Valve’ or ‘Valve-in-Ring’ procedures currently performed in patients with degenerated previously implanted surgical prostheses.”

The procedure was conducted using a transapical (between the ribs in the chest) delivery approach. The transfemoral approach (through the arteries in the leg) is generally considered the most desirable for transcatheter devices.

Following the clinical and economic success of TAVRs, investors are supportive of bigwigs’ move to enter what promises to be an even more lucrative arena. But left ventricular assist device specialist HeartWare ($HTWR) saw its stock fall 20% when it announced the acquisition of Israel’s Valtech Cardio, which is developing transcatheter and surgical devices for mitral valve repair and replacement. Compounding matters, activist investor Engaged Capital just took a 5% stake in the company and is campaigning to block the transaction.

Still, TMVR is a must-(pay-to-)play market for cardiology generalists like Boston Scientific. So far, the bigwigs have focused on mitral valve replacement, but mitral valve repair is showing promise too, as evidenced by the recent $5 million Series A financing round for Germany’s coramaze technologies.

The only approved transcatheter devices for the mitral valve are in the repair arena, led by Abbott’s FDA-approved Mitraclip, which earns $250 million per year. Cardiac Dimension’s Carillon device and Valtech’s Cardioband have CE marks.

Expect more data from aspirants like Harpoon Medical at the upcoming Transcatheter Therapies Conference in San Francisco. Due to the surge in dealmaking for mostly unapproved devices, several early-stage companies are exiting stealth mode.

But not MValve. The company doesn’t have a website, for it doesn’t need suitors due to Boston Scientific’s financial backing and $200 million option.

SOURCE

http://www.fiercemedicaldevices.com/story/boston-scientific-announces-200m-option-purchase-israeli-transcatheter-mitr/2015-10-08?utm_medium=nl&utm_source=internal

Other related articles on this topic published in this Open Access Online Scientific Journal, including the following:

http://pharmaceuticalintelligence.com/?s=Mitral+Valve

Read Full Post »

US Patents for METHOD AND APPARATUS FOR REPAIRING A MITRAL VALVE

Reporter: Aviva Lev-Ari, PhD, RN

Personal email exchange with Ed Hlozek:

This is still an implantable surgical device , albeit in a minimally invasive fashion.  Patient population is the same surgical patient population.  Check out Mitraspan. The website is almost a non-entity, but:

http://www.faqs.org/patents/app/20130211513

In the column on the right are other patents listed…all implantables, and all MIS.  It remains to be seen if these novo implantables will be able to mimic the results achieved by the surgically implanted ring, the current gold standard for repair of the mitral valve  (assuming leaflet integrity).  Annual surgical procedures are still in the 150,000 range annually.

SOURCE

From: Edward Hlozek <mind.and.associates.inc@gmail.com> on behalf of Edward Hlozek <ehlozek@valvecure.com>

Date: Tuesday, October 6, 2015 at 1:14 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Cc: Justin MDMEPhD <jdpmdphd@gmail.com>, Gerard Loiseau <gerard.loiseau@bluewin.ch>

Subject: Re: FW: Acquisition of Valtech calling into question ?

HeartWare ($HTWR) was up about 5% in early trading on the news that activist investor Engaged Capital is opposing its acquisition of mitral valve player Valtech Cardio–and is seeking a renewed focus on LVAD with a possible sale of the company. HeartWare said in early September that it would buy Valtech for about $930 million in a cash and stock transaction, based on its share price at the time. If the deal is not terminated, Engaged Capital said it will continue to oppose it and seek board representation.

HeartWare shares quickly shed about 20% on the acquisition news when it was first disclosed, indicating that Engaged Capital isn’t alone in its disapproval of the deal, which takes the LVAD (left ventricular assist device) player into a new direction, adding Valtech’s mitral valve replacement and repair technology. Patients on LVAD often also concurrently receive a mitral or tricuspid valve procedure.

On Mon, Oct 5, 2015 at 2:41 PM, Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu> wrote:

All,

My read is as follows:

Heartware will complete the acquisition of ValTech for a Billion on top of its Market cap of a billion.

It will be in 4  month later be acquired for $3.5 Billion by Medtronic

Respectively the concentration in the Mitral Valve Repair and Replacement will be further tighten all small players will be driven out of the Scene by the 3-4 Players listed below.

A Case Study

MITRASPAN, INC.

Inventors:  Jonathan M. Rourke (Belmont, MA, US)  Mitraspan, Inc  Stanley B. Kyi (Andover, MA, US)
Assignees:  MITRASPAN, INC
IPC8 Class: AA61F224FI
USPC Class: 623 237
Class name: Heart valve annuloplasty device adjustable
Publication date: 2013-08-15
Patent application number: 20130211513

Abstract:

A method for repairing a mitral valve, the method comprising: positioning a crossing guidewire across the mitral valve, the crossing guidewire passing through the annulus of the mitral valve at a first location and passing through the annulus of the mitral valve at a second location; using the crossing guidewire to position a spanning implant across the mitral valve, with the spanning implant extending from the first location to the second location; anchoring the spanning implant at the first location; tensioning the spanning implant so as to draw the first location and the second location together; and anchoring the spanning implant at the second location.

Claims:

1. A method for repairing a mitral valve, the method comprising: positioning a crossing guidewire across the mitral valve, the crossing guidewire passing through the annulus of the mitral valve at a first location and passing through the annulus of the mitral valve at a second location; using the crossing guidewire to position a spanning implant across the mitral valve, with the spanning implant extending from the first location to the second location; anchoring the spanning implant at the first location; tensioning the spanning implant so as to draw the first location and the second location together; and anchoring the spanning implant at the second location.

2. A method according to claim 1 wherein the mitral valve is accessed by penetrating the wall of the left ventricle in the vicinity of the apex.

3. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart; passing a first guidewire from the left ventricle to the left atrium at the first location; passing the first guidewire from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field; passing a second guidewire from the left ventricle to the left atrium at the second location; passing the second guidewire from the left atrium through the valve leaflets, through the left ventricle and out to the operative sterile field; terminating an end of the first guidewire to an end of the second guidewire at the operative sterile field so as to create the complete crossing guidewire; and passing the termination from the operative sterile field, through the left ventricle, through the valve leaflets, to the left atrium.

4. A method according to claim 3 wherein the first guidewire is passed from the left ventricle to the left atrium at the first location by advancing a first positioning sheath through the left ventricle so that the distal end of the first positioning sheath is positioned against the annulus at the first location, advancing a first curved tube out of the first positioning sheath and through the annulus at that first location, and advancing the first guidewire through the first curved tube and into the left atrium.

5. A method according to claim 4 wherein the first curved tube has a sharp distal end so that it may be pushed through the annulus.

6. A method according to claim 4 wherein the first curved tube receives an RF wire therein, and further wherein the RF wire is used to create an opening in the annulus for receiving the first curved tube.

7. A method according to claim 3 wherein the first guidewire is passed from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field by advancing a snare from the left ventricle, through the valve leaflets and into the left atrium, snaring the first guidewire with the snare, and retracting the snare from the left atrium, through the valve leaflets and through the left ventricle.

8. A method according to claim 3 wherein the second guidewire is passed from the left ventricle to the left atrium at the second location by advancing a second positioning sheath through the left ventricle so that the distal end of the second positioning sheath is positioned against the annulus at the second location, advancing a second curved tube out of the second positioning sheath and through the annulus at that second location, and advancing the second guidewire through the second curved tube and into the left atrium.

9. A method according to claim 8 wherein the second curved tube has a sharp distal end so that it may be pushed through the annulus.

10. A method according to claim 8 wherein the second curved tube receives an RF wire therein, and further wherein the RF wire is used to create an opening in the annulus for receiving the second curved tube.

11. A method according to claim 3 wherein the second guidewire is passed from the left atrium through the valve leaflets, through the left ventricle and out to an operative sterile field by advancing a snare from the left ventricle, through the valve leaflets and into the left atrium, snaring the second guidewire with the snare, and retracting the snare from the left atrium, through the valve leaflets and through the left ventricle.

12. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart; passing the crossing guidewire from the left ventricle to the left atrium at the first location; passing a funnel-shaped snare from the left ventricle to the left atrium at the second location; capturing the crossing guidewire with the funnel-shaped snare in the left atrium; retracting the funnel-shaped snare and captured crossing guidewire through the annulus at the second location and through the left ventricle.

13. A method according to claim 1 wherein the crossing guidewire is positioned by accessing the left ventricle of the heart; passing the crossing guidewire from the left ventricle to the left atrium at the first location; passing an inflatable funnel from the left ventricle to the left atrium at the second location while the inflatable funnel is in a deflated condition; inflating the inflatable funnel; advancing the crossing guidewire into the inflatable funnel and through the annulus at the second location, and through the left ventricle.

14. A method according to claim 1 wherein the spanning implant is positioned across the mitral valve by attaching the spanning implant to the crossing guidewire and using the crossing guidewire to pull the spanning implant into position.

15. A method according to claim 1 wherein the spanning implant comprises a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture.

16. A method according to claim 15 wherein the spanning implant is anchored at the first location using the first anchor.

17. A method according to claim 15 wherein the first anchor is positioned on the ventricular side of the annulus.

18. A method according to claim 15 wherein the spanning implant is anchored at the second location using the second anchor.

19. A method according to claim 15 wherein the second anchor is positioned on the ventricular side of the annulus.

20. A method according to claim 1 wherein the spanning implant is dynamically tensioned while observing changes in the function of the mitral valve.

21. Apparatus for repairing a mitral valve, the apparatus comprising: a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture.

22. Apparatus according to claim 21 wherein the second end of the suture is configured to be secured to a guidewire.

23. Apparatus according to claim 21 wherein the first anchor comprises a T-bar anchor.

24. Apparatus according to claim 23 further comprising a control line releasably secured to the T-bar anchor.

25. Apparatus according to claim 21 wherein the second anchor comprise a T-bar anchor.

26. Apparatus according to claim 21 wherein the coaxial suture lock is configured to bind to the suture upon the application of a compressive radial force to the coaxial suture lock.

27. Apparatus for repairing a mitral valve, the apparatus comprising: a crossing guidewire extending from the left ventricle, through the annulus at a first location, into the left atrium, through the annulus at a second location, and into the left ventricle.

28. Apparatus for repairing a mitral valve, the apparatus comprising: a positioning sheath having a distal end, a proximal end, and a lumen extending therebetween, the positioning sheath being configured to extend across the left ventricle and contact the annulus of the mitral valve at a first location, with the distal end of the positioning sheath set so that the lumen of the positioning sheath is aimed into the left atrium; and a curved tube having a distal end, a proximal end, and a lumen extending therebetween, the curved tube being configured to telescopically extend through the positioning sheath, across the annulus at the first location and present its distal end substantially parallel to the plane of the mitral valve annulus.

29. Apparatus according to claim 28 further comprising a guidewire sized to be telescopically disposed within the curved tube.

30. Apparatus according to claim 29 further comprising a snare for capturing the guidewire when the guidewire is telescopically advanced out of the distal end of the curved tube.

31. Apparatus according to claim 28 further comprising: a second positioning sheath having a distal end, a proximal end, and a lumen extending therebetween, the second positioning sheath being configured to extend across the left ventricle and contact the annulus of the mitral valve at a second location, with the distal end of the second positioning sheath set so that the lumen of the second positioning sheath is aimed into the left atrium; a second curved tube having a distal end, a proximal end, and a lumen extending therebetween, the second curved tube being configured to telescopically extend through the second positioning sheath, across the annulus at the second location and present its distal end substantially parallel to the plane of the mitral valve annulus; and a guidewire extendable through the first curved tube and receivable within the second curved tube.

32. Apparatus according to claim 31 further comprising a suture having a first end and a second end, a first anchor secured to the first end of the suture, a second anchor slidably mounted to the second end of the suture, and a coaxial suture lock for locking the second anchor to the suture, and further wherein the second end of the suture is releasably secured to the guidewire.

SOURCE

http://www.faqs.org/patents/app/20130211513

Similar patent applications:
Date Title
2013-09-12 Method for anchoring a mitral valve
2013-10-10 Device and method for reducing mitral valve regurgitation
2009-05-07 Method and apparatus for improving mitral valve function
2010-02-11 Method and apparatus for improving mitral valve function
2012-01-26 Method for preparing biomedical surfaces
New patent applications in this class:
Date Title
2015-05-28 Anti-paravalvular leakage component for a transcatheter valve prosthesis
2015-05-21 Reconfiguring tissue features of a heart annulus
2015-03-19 Implant and anchor placement
2015-01-08 Implant having multiple rotational assemblies
2014-11-13 Methods and apparatus for controlling the internal circumference of an anatomic orifice or lumen
New patent applications from these inventors:
Date Title
2015-05-14 Method and apparatus for repairing a mitral valve
Top Inventors for class “Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor”
Rank Inventor’s name
1 Anton G. Clifford
2 Jan Weber
3 Yunbing Wang
4 Blayne A. Roeder
5 Robert Metzger

Read more: http://www.faqs.org/patents/app/20130211513#ixzz3nohClWxF
Read more: http://www.faqs.org/patents/app/20130211513#ixzz3nogUCtxl
Read more: http://www.faqs.org/patents/app/20130211513#ixzz3noaQWHo9

Adjustable Subclass of:

623 – Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor

623200100 – HEART VALVE

623200360 – Annuloplasty device

Patent class list (only not empty are listed)

Deeper subclasses:

http://www.faqs.org/patents/class/000553012

SOURCE:

http://www.faqs.org/patents/app/20130211513

 http://www.faqs.org/patents/app/20130211513#ixzz3noZtbMKS

Other related articles published in this Open Access Online Scientific Journal include the following:

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure?

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2013/11/04/mitral-valve-repair-who-is-a-candidate-for-a-non-ablative-fully-non-invasive-procedure/

Read Full Post »

Abbott’s percutaneous MitraClip mitral valve repair device SUPERIOR to Pacemaker or Implantable Cardioverter Defibrillator (ICD) for reduction of Ventricular Tachyarrhythmia (VT) episodes

Reporter: Aviva Lev-Ari, PhD, RN

Abbott’s MitraClip can cut arrhythmias in half, according to data from Heart Rhythm conference

The researchers studied 50 patients before and after implantation of the MitraClip over 20 months. There were 68 sustained VT episodes in the patient prior to implantation, and 30 after. The number of long-lasting episodes (those with a cycle length of more than 300 milliseconds) recorded was 46 prior to implantation and 21 episodes following use of the MitraClip.

The number of non-significant VT episodes fell from 56 to 49 after implantation, a statistically insignificant difference.

“We can show that the MitraClip therapy results in a significant reduction in ventricular arrhythmia burden, especially in ICD patients,” said Dr. Cathrin Theis during the May 14 presentation, according to MassDevice.

Studies demonstrating efficacy of the MitraClip are crucial because the device got FDA’s approval in 2013 despite the results from its pivotal trial, which found that MitraClip posted almost no clinical benefits over traditional valve surgery after four years.

On top of this study comparing the device to ICDs, experts at the annual meeting of the American College of Cardiology said post market registry data collected on the MitraClip shows that the device is safe and effective, for the primary clinical benefit of a reduction in mitral regurgitation was achieved in 63.7% of patients.

The MitraClip is meant to treat mitral regurgitation, which is associated with ventricular tachyarrhythmia. Mitral regurgitation involves a leaky heart valve that lets blood flow backward and can cause irregular heartbeats, stroke or heart failure. MitraClip is delivered via catheter through the femoral vein in the leg, and it clips together parts of the mitral valve. The solution is meant to be less invasive than regular surgery.

“The market opportunity for mitral regurgitation is significant but still in its early stages, and MitraClip is the only product on the market to-date that can treat this disease in a minimally invasive way,” said Abbott CEO Miles White during its most recent earnings call.

He said sales of the device increased at a double-digit rate in both the U.S. and abroad.

– read the study
– here’s MassDevice‘s take

Related Articles:
Registry data shows Abbott’s MitraClip transcatheter valve is performing well in real-world settings
Abbott wins Medicare coverage, new tech add-on payments for MitraClip cardiology device
Abbott’s MitraClip heart valve device gains FDA’s long-awaited blessing
Four year results: Abbott’s MitraClip no better than surgery

SOURCE

http://www.fiercemedicaldevices.com/story/data-presented-cardiology-conference-show-abbotts-mitraclip-can-cut-arrhyth/2015-05-15?utm_campaign=AddThis&utm_medium=AddThis&utm_source=mailto#.VVsoG2yN4ik.mailto

Read Full Post »

« Newer Posts - Older Posts »

%d bloggers like this: