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Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category


Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016

Reporter: Aviva Lev-Ari, PhD

 

Acquisitions of small players marks the ENTRY of Edwards LifeSciences into the Mitral Valve Repair Market, following MAJOR success in TAVR.

  • Harpoon Medical (trans apical approach) in 12/2017 and 
  • CardiAQ Valve Technologies in 8/2016
  • $690 million buyout of Valtech Cardio, 1/2017 –  It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

 

 

Edwards buys mitral valve repair player in $250M deal – Harpoon Medical

“The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment to innovation in cardiac surgery.”

The HARPOON system is designed to facilitate echo-guided repair of mitral valve regurgitation, by stabilizing the prolapsed mitral valve leaflet to restore proper coaptation and valve function.  The HARPOON device is currently investigational and not available for commercial use. It is expected to receive CE Mark approval soon.

“There are a significant number of patients currently undergoing mitral valve surgery that we believe can benefit from Harpoon’s therapy during a minimally invasive, beating-heart procedure,” said device inventor James S. Gammie, M.D., chairman of the company’s scientific advisory board and professor and chief of cardiac surgery at the University of Maryland School of Medicine. “This therapy offers the potential for earlier treatment of degenerative mitral valve disease with faster recovery and less morbidity, while also providing the opportunity for more consistent procedures and outcomes for patients.”

Edwards will discuss the HARPOON technology further at its annual Investor Conference on Dec. 7.

Edwards Lifesciences closes $690m Valtech Cardio buy

Edwards Lifesciences, Valtech CardioEdwards Lifesciences (NYSE:EW) said yesterday that it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.

Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

Or Yehuda, Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.) Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.

“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” Edwards chairman & CEO Michael Mussallem said in prepared remarks.

Edwards Lifesciences bought CardiAQ Valve Technologies and its mitral valve device for $400 million last August.

Shares in Edwards have plummeted today in mid-day trading, down 9.1% at $89.06 as of 12:45 p.m. EST.

Last month, Edwards said it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.

Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.

SOURCE

http://www.massdevice.com/edwards-pauses-cardiaq-valve-clinical-trial-enrollment/

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Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Reporter: Aviva Lev-Ari, PhD, RN

 

VIEW VIDEO

https://www.dicardiology.com/videos/video-update-mitral-valve-repair-and-replacement-technologies/5638263949001?eid=333021707&bid=1921231

 

 

HEART VALVE TECHNOLOGY | NOVEMBER 07, 2017

Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, explains the current state of transcatheter mitral valve technologies in development and in trials. He is involved in some of these trials and was the principal investigator for the pivotal MitraClip trial. Watch the VIDEO “Transcatheter Mitral Valve Technology, Anatomical Challenges” with Juan Granada, M.D.. Read the articles “Advances and Future Directions for Transcatheter Valves,” and “Transcatheter Mitral Valve Replacement Devices in Development.”

  • MitraClip 
  • Cardioband

 

SOURCE

https://www.dicardiology.com/videos/video-update-mitral-valve-repair-and-replacement-technologies/5638263949001?eid=333021707&bid=1921231

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cell-free DNA (cfDNA) tests could become the ultimate “Molecular Stethoscope” that opens up a whole new way of practicing Medicine

 

Reporter: Aviva Lev-Ari, PhD, RN

The first commercial application of cfDNA sequencing debuted in 2011. New blood tests can identify Down’s syndrome and similar genetic conditions during the first months of pregnancy by checking the fetal DNA in the bloodstream of a pregnant woman. (Anywhere from 10 to 15 percent of the DNA in a pregnant woman’s blood comes from the placenta, which is genetically similar to the fetus.) These maternal blood tests are fast replacing less-accurate procedures, such as ultrasound plus blood analysis.

More recently, researchers have started looking at cfDNA to develop so-called liquid biopsies, which analyze a tumor’s genetic makeup or look for evidence of a cancer recurrence. Tumors often spill DNA into the blood as they grow and divide, and because they are usually riddled with mutations, their scrambled DNA is clearly different from that found in normal DNA fragments. The first liquid biopsy test was launched only three years ago; although they are not yet part of routine care, the field is growing quickly. One company says it will give liquid biopsy tests to one million people in the next five years, and another has raised nearly $1 billion for its studies.

A similar cfDNA method is being tested for newly transplanted organs, which are at risk of being rejected by the recipient’s immune system. Currently, transplant doctors check a transplanted organ’s health by performing repeated biopsies, which are expensive and invasive. After a transplant small amounts of donor DNA from the new heart or kidney, for example, circulate in the blood as part of the normal process of cell birth and death. If the host immune system attacks the foreign organ, the proportion of donor DNA increases as more and more foreign cells die. One company, CareDx, already sells a test that picks up on that change for people who have had kidney transplants.

The researchers invented a way to boost the signal by reducing human DNA in blood samples. Their spin-off company, Karius, launched a test earlier this year to identify bacteria, fungi, viruses or parasites in hospitalized patients. It can spot infections in organs that are too dangerous for biopsies, including the lung and the brain, Kertesz says—and it is most useful for people with mystery infections or who are too sick to endure a surgery.

cell-free DNA tests in the future include stroke, or autoimmune conditions such as lupus

 

SOURCE

One Test May Spot Cancer, Infections, Diabetes and More

Researchers are starting to diagnose more ailments using DNA fragments found in the blood

https://www.scientificamerican.com/article/one-test-may-spot-cancer-infections-diabetes-and-more/

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Cleveland Clinic: Change at the Top,  Tomislay “Tom” Mihaljevic, M.D., as its next CEO and President to succeed Toby Cosgrove, M.D., effective Jan. 1, 2018

Reporter: Aviva Lev-Ari, PhD, RN

 

Cleveland Clinic’s Board of Governors and Board of Directors unanimously selected Dr. Mihaljevic based on the unanimous recommendation of a nomination committee chaired by Mr. Rich that conducted an extensive review of potential successors. Drs. Cosgrove and Mihaljevic will work on a transition process together through the end of the year. As of Jan. 1, 2018, Dr. Mihaljevic will assume the full duties of president and CEO, while Dr. Cosgrove will move to an advisory role to be determined by the Board of Directors and Dr. Mihaljevic.

A native of Croatia and a naturalized American citizen, Dr. Mihaljevic earned his medical degree from the University of Zagreb, before moving to the United States in 1995 to join Brigham and Women’s Hospital in Boston. He moved to Cleveland Clinic in 2004 as a cardiothoracic surgeon specializing in minimally invasive and robotically assisted cardiac surgeries – particularly robotic mitral valve repair – complex valve operations and reoperations, heart failure surgery, and heart transplantation. He helped to build Cleveland Clinic into the world’s largest robotic practice.

Dr. Mihaljevic has been on the editorial review board for prestigious medical journals. He is the author or co-author of more than 145 articles in medical and peer-reviewed scientific journals, and is the author of a numerous textbook chapters on robotic and minimally invasive mitral valve surgery, and heart valve disease. In 2005, Dr. Mihaljevic received a patent for a novel cardioscopy system for minimally invasive cardiac surgery. He earned the Cleveland Clinic Innovation Award in both 2006 and 2007.

Dr. Mihaljevic, 53, joined Cleveland Clinic in 2004 as a cardiothoracic surgeon specializing in minimally invasive and robotically assisted cardiac surgeries. Since 2015, Dr. Mihaljevic has served as CEO of Cleveland Clinic Abu Dhabi, overseeing the hospital’s strategy and operations as the first US multispecialty hospital to be replicated outside of North America, including directly managing the hospital’s Patient Experience and Strategy & Business Development programs.

Tomislav Mihaljevic, M.D. 

“Dr. Mihaljevic brings a depth of experience, first as an innovative, world-class surgeon and more recently as a hospital executive focused on healthcare quality and safety, patient experience and business strategy,” said Robert E. Rich Jr., chair of Cleveland Clinic’s Board of Directors. “By nearly every measure – quality, accessibility, finances, innovation, reputation – Cleveland Clinic has made unprecedented strides since Dr. Cosgrove became CEO and president in 2004. Following in his footsteps would be challenging for anybody, but Dr. Mihaljevic has the background, skills and vision to move Cleveland Clinic forward to even greater heights.”

SOURCE

https://newsroom.clevelandclinic.org/2017/09/01/tomislav-mihaljevic-m-d-named-cleveland-clinic-ceo-president/

 

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

 

Articles on Minimally Invasive Surgery (MIS)

Cardiovascular Complications: Death from Reoperative Sternotomy after prior CABG, MVR, AVR, or Radiation; Complications of PCI; Sepsis from Cardiovascular Interventions

Author, Introduction and Summary: Justin D Pearlman, MD, PhD, FACC, and Article Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/23/cardiovascular-complications-of-multiple-etiologies-repeat-sternotomy-post-cabg-or-avr-post-pci-pad-endoscopy-andor-resultant-of-systemic-sepsis/

 

Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/05/17/less-is-more-minimalist-mitral-valve-repair-expert-opinion-of-prem-s-shekar-md-chief-division-of-cardiac-surgery-bwh-7-2017-disruptive-dozen-at-wmif17/

 

Left Main Coronary Artery Disease (LMCAD): Stents vs CABG – The less-invasive option is Equally Safe and Effective

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/12/06/left-main-coronary-artery-disease-lmcad-stents-vs-cabg-the-less-invasive-option-is-equally-safe-and-effective/

 

New method for performing Aortic Valve Replacement: Transmural catheter procedure developed at NIH, Minimally-invasive tissue-crossing – Transcaval access, abdominal aorta and the inferior vena cava

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/10/31/new-method-for-performing-aortic-valve-replacement-transmural-catheter-procedure-developed-at-nih-minimally-invasive-tissue-crossing-transcaval-access-abdominal-aorta-and-the-inferior-vena-cava/

 

Minimally Invasive Valve Therapy Programs: Recommendations by SCAI, AATS, ACC, STS

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/05/19/minimally-invasive-valve-therapy-programs-recommendations-by-scai-aats-acc-sts/

 

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

Author, and Content Consultant to e-SERIES A: Cardiovascular Diseases: Justin Pearlman, MD, PhD, FACC and Article Curator: Aviva Lev-Ari, PhD, RN

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

 

Call for the abandonment of the Off-pump CABG surgery (OPCAB) in the On-pump / Off-pump Debate, +100 Research Studies

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/31/call-for-the-abandonment-of-the-off-pump-cabg-surgery-opcab-in-the-on-pump-off-pump-debate-100-research-studies/

 

3D Cardiovascular Theater – Hybrid Cath Lab/OR Suite, Hybrid Surgery, Complications Post PCI and Repeat Sternotomy

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/19/3d-cardiovascular-theater-hybrid-cath-labor-suite-hybrid-surgery-complications-post-pci-and-repeat-sternotomy/

 

Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeonat Peak Career – Richard Paul Cambria, MD

Author and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/14/vascular-surgery-position-statement-in-2013-and-contributions-of-a-vascular-surgeon-at-peak-career-richard-paul-cambria-md-chief-division-of-vascular-and-endovascular-surgery-co-director-thoracic/

 

Becoming a Cardiothoracic Surgeon: An Emerging Profile in the Surgery Theater and through Scientific Publications 

Author and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/07/08/becoming-a-cardiothoracic-surgeon-an-emerging-profile-in-the-surgery-theater-and-through-scientific-publications/

 

Carotid Endarterectomy (CEA) vs. Carotid Artery Stenting (CAS): Comparison of CMMS high-risk criteria on the Outcomes after Surgery:  Analysis of the Society for Vascular Surgery (SVS) Vascular Registry Data

Writer and Caurator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/28/effect-on-endovascular-carotid-artery-repair-outcomes-of-the-cmms-high-risk-criteria/

 

Open Abdominal Aortic Aneurysm (AAA) repair (OAR) vs. Endovascular AAA Repair (EVAR) in Chronic Kidney Disease (CKD) Patients –  Comparison of Surgery Outcomes

Writer and Curator: Larry H. Bernstein, MD, FCAP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/28/the-effect-of-chronic-kidney-disease-on-outcomes-after-abdominal-aortic-aneurysm-repair/

 

 

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SNP-based Study on high BMI exposure confirms CVD and DM Risks – no associations with Stroke

Reporter: Aviva Lev-Ari, PhD, RN

Genes Affirm: High BMI Carries Weighty Heart, Diabetes Risk – Mendelian randomization study adds to ‘burgeoning evidence’

by Crystal Phend, Senior Associate Editor, MedPage Today, July 05, 2017

 

The “genetically instrumented” measure of high BMI exposure — calculated based on 93 single-nucleotide polymorphisms associated with BMI in prior genome-wide association studies — was associated with the following risks (odds ratios given per standard deviation higher BMI):

  • Hypertension (OR 1.64, 95% CI 1.48-1.83)
  • Coronary heart disease (CHD; OR 1.35, 95% CI 1.09-1.69)
  • Type 2 diabetes (OR 2.53, 95% CI 2.04-3.13)
  • Systolic blood pressure (β 1.65 mm Hg, 95% CI 0.78-2.52 mm Hg)
  • Diastolic blood pressure (β 1.37 mm Hg, 95% CI 0.88-1.85 mm Hg)

However, there were no associations with stroke, Donald Lyall, PhD, of the University of Glasgow, and colleagues reported online in JAMA Cardiology.

The associations independent of age, sex, Townsend deprivation scores, alcohol intake, and smoking history were found in baseline data from 119,859 participants in the population-based U.K. Biobank who had complete medical, sociodemographic, and genetic data.

“The main advantage of an MR approach is that certain types of study bias can be minimized,” the team noted. “Because DNA is stable and randomly inherited, which helps to mitigate errors from reverse causality and confounding, genetic variation can be used as a proxy for lifetime BMI to overcome limitations such as reverse causality and confounding, a process that hampers observational analyses of obesity and its consequences.”

 

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

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    Cardiovascular Original Research: Cases in Methodology Design for Content Co-Curation: The Art of Scientific & Medical Curation

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Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Reporter and Curator: Aviva Lev-Ari, PhD, RN

 

 

Philips to buy medical device maker Spectranetics for 1.9 billion euros

By Toby Sterling | AMSTERDAM

Dutch healthcare company Philips (PHG.AS) has agreed to buy U.S.-based Spectranetics Corp (SPNC.O), a maker of devices to treat heart disease, for 1.9 billion euros (£1.68 billion) including debt, as it expands its image-guided therapy business.

Spectranetics uses techniques including lasers and tiny drug-covered balloons to clean the insides of veins and arteries that have become clogged due to heart disease.

Philips will pay Spectranetics shareholders $38.50 per share, a 27 percent premium to their closing price on June 27.

Philips Chief Executive Frans van Houten has transformed the former conglomerate into a focused maker of healthcare equipment over the past five years, spinning off its lighting division (LIGHT.AS) and selling most of its remaining consumer products business.

Philips said Spectranetics, which expects sales of around $300 million this year, will continue to grow revenues at double-digit rates and will begin adding to Philips’ earnings in 2018.

SOURCE

http://uk.reuters.com/article/uk-spectranetics-m-a-philips-idUKKBN19J0MZ?em_pos=small&ref=headline&nl_art=1

Home / About Spectranetics / Overview

http://www.spectranetics.com/about/overview/

Spectranetics’ History – 30 years of Innovations and M&A

http://www.spectranetics.com/about/history/

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Coronary Intervention

Coronary Artery Disease (CAD) is the leading cause of death among men and women. Each year, one in four deaths are attributed to CAD in the United States, accounting for over a half million lives lost. From scoring balloon technology to laser atherectomy to thrombus aspiration and removal, Spectranetics offers a comprehensive portfolio of solutions to cross, prep and treat compromised vessels. Learn more about CAD by navigating through the tile grid below and exploring the products that are saving lives.

SOURCE

http://www.spectranetics.com/solutions/coronary-intervention/

 

 Peripheral Intervention

Spectranetics is dedicated to helping physicians cross, prep and treat complex clinical challenges of Peripheral Artery Disease, such as Critical Limb Ischemia, Chronic Total Occlusions and In-Stent Restenosis. We provide expert tools, training, ongoing support and patient education so that you can help eradicate restenosis, and amputation and modify all plaque. Explore the tile grid below to learn more about Peripheral Artery Disease and Spectranetics’ comprehensive portfolio of products to successfully treat this challenging cardiovascular condition at every stage.

Products

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Lead Management

Managing cardiac implantable electronic device (CIED) leads has never been more important. Patients with CIEDs are on a lifelong journey, and Spectranetics is there to make sure it’s a healthy one. Making the right decision at the right time, for every patient, is critical. Lives depend on it. Explore the tile grid below to learn more about Lead Management and the products that ensure lead extraction is done safely, responsibly and predictably.

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Off-Label TAVR Procedures: 1 in 10 associated with higher in-hospital 30-day mortality, 1-year mortality was similar in the Off-Label and the On-Label groups

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/10, 2017

FDA clears Medtronic’s CoreValve Evolut TAVR in intermediate risk patients

JULY 10, 2017 BY FINK DENSFORD

http://www.massdevice.com/fda-clears-medtronics-corevalve-evolut-tavr-in-intermediate-risk-patients/?spMailingID=11443122&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1200865729&spReportId=MTIwMDg2NTcyOQS2

 

 

  • by Nicole Lou, Reporter, MedPage Today/CRTonline.org June 21, 2017

Action Points

  • Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
  • Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

Three-quarters of off-label indications were deemed so due to presence of severe aortic or mitral regurgitation or both; one-fifth were off-label because of bicuspid valves.

Successful device implantation was slightly less likely with off-label TAVR (92.9% versus 93.0%, P=0.02). But in-hospital outcomes were the bigger issue for off- versus on-label TAVR:

  • Mortality (6.3% versus 4.7%, P<0.001)
  • Cardiac arrest (6.6% versus 4.8%, P<0.001)
  • Transient ischemic attack (0.5% versus 0.2%, P=0.007)
  • Moderate-to-severe perivalvular leaks (12.4% versus 7.6%, P<0.001)

Mortality was most likely for patients with severe mitral regurgitation as the only off-label indication for TAVR. The authors suggested this is owing to secondary mitral regurgitation caused by left ventricular dilatation.

SOURCE

1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry

https://www.medpagetoday.com/Cardiology/CHF/66173?xid=nl_mpt_DHE_2017-06-22&eun=g99985d0r&pos=1

Other related TAVR articles published in this Open Access Online Scientific Journal included the following 64 articles:

https://pharmaceuticalintelligence.com/?s=TAVR

 

 

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