FDA approves 4th-gen MitraClip for TMVR Updated Issue with Delivery System Deployment Process: MitraClip Clip Recalled by Abbott Vascular

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FDA approves 4th-gen MitraClip for TMVR Updated Issue with Delivery System Deployment Process: MitraClip Clip Recalled by Abbott Vascular

March 21, 2016 by 2012pharmaceutical

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

Dave Fornell | April 07, 2022 | Structural Heart Disease

VIDEO: MitraClip vs. surgical mitral valve replacement https://www.cardiovascularbusiness.com/node/213941

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.orgNovember 20, 2019

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

July 16, 2019 | Anicka Slachta | Structural & Congenital Heart Disease

Abbott’s fourth-generation MitraClip device was approved by the FDA July 15 to treat mitral regurgitation (MR) in a wider population of patients, the company announced this week.

MitraClip, first approved by the FDA in 2013 for use in primary MR patients, facilitates transcatheter mitral valve repair (TMVR) by “clipping” a patients’ valve leaflets together to reduce backflow of blood into the heart. It was the landmark COAPT trial that again drew attention to the therapy in 2018, and this March the FDA greenlighted the MitraClip for use in patients with secondary MR.

The latest iteration of the system, dubbed MitraClip G4 by Abbott, allows physicians more flexibility with four unique clip sizes, including clips with a wider grasping area to provide additional treatment options. MitraClip G4 also features independently controlled grippers that better help physicians grasp one or both mitral leaflets during TMVR.

The latest device allows physicians to integrate the upgraded MitraClip catheter with a commercially available pressure monitor to continuously track and confirm MR reduction during the implant procedure. The MitraClip catheter can be paired with the monitor for real-time left atrial pressure monitoring during the procedure.

“We are continually innovating the MitraClip technology based on the experience of the physicians implanting the device so we can truly help them improve the lives of their patients,” Neil Moat, MD, chief medical officer of Abbott’s structural heart branch, said in a statement. “With the fourth generation of MitraClip, we set out to build a system that would help physicians individualize the therapy to each patient and deliver even more features that can treat both primary and secondary mitral regurgitation.”

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 TodaySeptember 19, 2018

This article is a collaboration between MedPage Today® and:

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

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

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