Boston Scientific to submit last FDA PMA module for Lotus Edge aortic valve this month
Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week. The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years. Last November, Boston Scientific announced news of a delay that resulted in a $3 billion drop in its market capitalization. Earlier that year in February, the company recalled the Lotus TAVR system over issues with its locking mechanism and said it didn’t expect to be able to get the d...
Source: Mass Device - August 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Replacement Heart Valves Boston Scientific Source Type: news

LivaNova Looking to Be a Standout Firm in TMVR
LivaNova is getting closer to becoming a major player in the transcatheter mitral valve replacement (TMVR) space. The company, which was formed when Sorin Group and Cyberonics merged back in 2015, said it has concluded, PRELUDE, the U.S. feasibility study of its TMVR technology. With the conclusion of PRELUDE, the London-based company will now focus on enrolling patients into its INTERLUDE CE mark trial and finalize the protocol for, ENSEMBLE, the U.S. pivotal trial. PRELUDE is a first-in-human study that evaluates the Caisson TMVR system to treat moderate to severe mitral regurgitation, using a transseptal approach. This ...
Source: MDDI - August 6, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Post-TAVR ECG Indicates Risk of Later Conduction Disturbances
(MedPage Today) -- Abnormal findings linked to high-degree conduction defects within 30 days of transcathether aortic valve replacement (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 6, 2018 Category: Cardiology Source Type: news

LivaNova touts completion of 1st-in-man transseptal Caisson TMVR feasibility study
LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation. In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses a catheter inserted through an incision in the groin instead of an opening in the chest. LivaNova touted “positive patient outcomes” from the study, but has not released data from it. The company said that...
Source: Mass Device - August 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves LivaNova Source Type: news

Increase in Proportion of TAVR Used From 2012 to 2015
MONDAY, Aug. 6, 2018 -- From 2012 to 2015, there was an increase in the number of patients overall and age 65 years and younger receiving transcatheter aortic valve replacement (TAVR), according to a research letter published online July 23 in the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 6, 2018 Category: Pharmaceuticals Source Type: news

JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who are considered at extreme or high risk for open surgery. “Both myself and my CUMC colleagues, Dr. Susheel Kodali and Dr. Torsten Vahl, are extremely pleased to be the first U.S. physicians to treat patients wit...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves JenaValve Source Type: news

JenaValve Getting Closer to its U.S. TAVR Goal
JenaValve Technology is continuing to make progress in bringing its transcatheter aortic valve replacement (TAVR) system to the U.S. market. The Irvine, CA-based company has initiated patient enrollment in an early feasibility study (EFS) of its next generation JenaValve Pericardial TAVR system. The EFS is a prospective, single-arm study of the JenaValve Pericardial TAVR System being conducted at several centers U.S. under an FDA-approved IDE. It is part of a larger, ongoing CE mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers in Europe and New Zealand. â...
Source: MDDI - August 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Microsoft ’s is developing a glasses-based blood pressure monitor
Microsoft (NSDQ:MSFT)  is developing new blood pressure monitoring tech, called Glabella, which comes equipped on a pair of glasses that passively collects physiological data on the wearer, according to a research paper recently released by the company. A prototype version of the glasses includes optical sensors, processing and storage and communications devices integrated into the frame to continuously collect data, according to the research paper. Sensors on the device collect reflected light intensities to measure blood flow, inertial measurements of the user’s head and temporal differences in pulse even...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Replacement Heart Valves Microsoft Corp. Source Type: news

Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced July 20, originally called for an up-front cash payment of $220 million plus the $50 million reimbursement milestone. That milestone was reached when the Centers for Medicare & Medicaid Services granted&n...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Valve-in-Valve TAVR Matches'Benchmark' of Native TAVR Valve-in-Valve TAVR Matches'Benchmark' of Native TAVR
Outcomes were similar or better compared with those of native-valve transcatheter aortic valve replacement, though longer follow-up will tell if it becomes the default strategy for most failed aortic valves.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 2, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

LivaNova beats Q2 expectations
LivaNova (NSDQ:LIVN) handily topped the consensus forecast for its second-quarter results despite a huge bottom-line slide. Formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, in April the company closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) and paid $250 million to acquire TandemLife and its cardiopulmonary temporary support solutions. LivaNova also acquired ImThera and its implantable sleep apnea treatment for $225 million early this year. LivaNova posted profits of $15.1 mill...
Source: Mass Device - August 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

CMS panel votes on volume requirements for TAVR centers
The Center for Medicare and Medicaid Services’ Medicare Evidence Development and Coverage Advisory Committee this week opened itself to comments and voted on volume requirements for new and existing transcatheter aortic valve replacement programs and operators. Panelists heard data from individuals across the healthcare spectrum, and ended up voting in the middle on most of the issues, according to a Medscape report. Voting was done on a one-to-five scale of confidence, with five showing high confidence in the resolution, according to the report. On considering hospitals with no TAVR experience opening new programs, ...
Source: Mass Device - July 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Source Type: news

Abbott Makes Strong Statement in TMVR Space with SUMMIT
Abbott Laboratories has hit a substantial milestone in its plan to bring the Tendyne transcatheter mitral valve replacement (TMVR) system to the U.S. market. The Abbott Park, IL-based company said it has initiated SUMMIT, a pivotal clinical study of the TMVR system. Up to 1,010 patients will be enrolled in up to 80 sites in the pivotal trial. Abbott said the investigational Tendyne device is the first and only mitral valve replacement that can be repositioned and fully retrieved, allowing the surgeon to precisely place the device during implantation, which could improve patient outcomes. Tendyne is a tri-leaflet, bioprost...
Source: MDDI - July 26, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Abbott launches pivotal US-based Tendyne TMVR trial
Abbott (NYSE:ABT) said today it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation. In the trial, the Abbott Park, Ill.-based company will explore the safety and efficacy of the system in treating patients with mitral regurgitation. Abbot touted the Tendyne as the first and only mitral valve replacement designed to be retrievable and repositionable. “Transcatheter mitral valve replacement represents a new frontier in treating people whose valve does not close properly and who would benefit from a replacement valve in...
Source: Mass Device - July 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Tendyne Holdings Source Type: news

Abbott Begins U.S. Pivotal Trial for the Tendyne Mitral Valve Replacement System to Treat Patients with Heart Valve Disease
- Investigational Tendyne device is first and only repositionable and fully retrievable mitral valve replacement (Source: Abbott.com)
Source: Abbott.com - July 26, 2018 Category: Pharmaceuticals Source Type: news

Endurance athlete hopes new heart valve technology will keep him active
An avid triathlete and marathon runner, Gil Solomon was concerned when an echocardiogram test done in 2014 showed that he had a congenital defect in his heart called bicuspid aortic valve disease. His aortic valve only had two cusps, or leaflets, that opened and closed to regulate blood flow instead of the normal three. The defect causes the valve to narrow, which strains the heart and reduces or blocks blood flow from the heart to the body. The same defect may also weaken the walls of the aorta, the main artery from the heart, which can lead to a tear.Many people, like Solomon, are unaware they have the condition until it...
Source: UCLA Newsroom: Health Sciences - July 25, 2018 Category: Universities & Medical Training Source Type: news

Meril Aims for Emerging Markets with its TAVR Device
Yet another company is throwing its hat into the transcatheter aortic valve replacement system (TAVR) market. However, Meril Lifesciences is going a different route than other established firms in the space and is initially targeting emerging markets. Meril has been around for 10 years and has been developing its MyVal TAVR technology for about six of those. The company’s success in TAVR lies around the fact that larger organizations don’t consider emerging markets as the first option. The company said it would seek out approval in India first and eventually make its way to developed markets. “We are posi...
Source: MDDI - July 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Tendyne investors sue Abbott over $50m milestone
Investors in Tendyne Holdings yesterday sued Abbott (NYSE:ABT) over a $50 million milestone payment, alleging that the healthcare giant dragged its heels on obtaining a regulatory approval that would have triggered a $50 million milestone payment. Abbott in September 2015 paid $225 million up front for the stake it didn’t already own in Roseville, Minn.-based Tendyne, which was developing a transcatheter replacement mitral valve. The deal also included a $50 million milestone provision contingent on the device winning CE Mark approval in the European Union before Dec. 31, 2017, and that ...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Legal News Mergers & Acquisitions Replacement Heart Valves Abbott Tendyne Holdings Source Type: news

Boston Sci Just Won ’t Stop Buying Companies
There really doesn’t seem to be in sight to Boston Scientific’s recent buying spree. This time the Marlborough, Mass.-based company is picking up Claret Medical for about $220 million in upfront cash and a potential reimbursement-based milestone payment of up to $50 million. The deal is set to close sometime in the third quarter of 2018. Santa Rosa, CA-based Claret has developed and received clearance for the Sentinel Cerebral Embolic Protection System. The device is used to protect the brain during certain interventional procedures, predominately in patients undergoing transcatheter aortic valve replacement(TA...
Source: MDDI - July 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news

Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentin...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Mitral Valve Operations Now Fastest-Growing Heart Surgery (CME/CE)
(MedPage Today) -- Earlier referral, though, needed to optimize outcomes (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - July 19, 2018 Category: Cardiology Source Type: news

FDA approves next-gen MitraClip from Abbott
Abbott (NYSE:ABT) won FDA approval for the third generation of its MitraClip transcatheter heart valve repair device, the company said today. Acquired in the $410 million acquisition of Evalve back in 2009, MitraClip won its first FDA nod in 2013. Abbott said today that the latest iteration won CE Mark approval in the European Union earlier this year. The new version upgrades MitraClip’s steering, navigation and positioning capabilities and a second clip size with expanded reach, the Chicago-area healthcare giant said. “Abbott engineers designed these enhancements based on feedback from doctors to improve ...
Source: Mass Device - July 12, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news

Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from ent...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Pulmonx Source Type: news

CMS Will Reconsider Its Stance on TAVR
Centers for Medicare & Medicaid Services (CMS) took an unprecedented stance in 2012 when it decided to cover transcatheter aortic valve replacement (TAVR) with strict restrictions regarding its use in patients with symptomatic aortic stenosis. One of the key issues regarding that CMS decision is that it included specific procedural volume restrictions, limiting the use of TAVR to high-volume hospitals and medical centers. Some doctors have argued that procedural volume is an outdated metric. To understand just how unprecedented the agency's decision on TAVR was six years ago, we look back at this MD+DI story quoti...
Source: MDDI - June 28, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

CMS opens NCA to reconsider TAVR coverage
The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures. Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers. Requirements in the 2012 decision included specific procedural volume requirements for heart teams and hospitals’ as well as mandatory participation in a registry. In a letter requesting reconsideration of the decision, Providence Health & Servi...
Source: Mass Device - June 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Edwards Lifesciences Source Type: news

JenaValve Keeps Steady Pace in the TAVR Market
JenaValve Technology is making steady progress in the development of its next-generation transcatheter aortic valve replacement (TAVR) system. The Irvine, CA-based company said it has implanted the initial patients in a CE mark study for the treatment of severe aortic regurgitation (AR). The CE mark study is an international, prospective, non-randomized, single-arm trial of the JenaValve Pericardial TAVR System for the treatment of AR in patients who are at increased risk for conventional surgical valve replacement. “Our goal is to enable the treatment of patients with severe aortic regurgitation while avoiding many ...
Source: MDDI - June 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

JenaValve launches CE Mark study of next-gen TAVR system
JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter. In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for conventional surgical valve replacement. “There is currently no TAVR treatment for severe aortic regurgitation cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVR valves that rely on t...
Source: Mass Device - June 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves JenaValve Source Type: news

Reduced-Intensity Warfarin Safe With On-X Heart Valve Reduced-Intensity Warfarin Safe With On-X Heart Valve
Low-dose warfarin plus aspirin was associated with less bleeding without increasing thromboembolic events compared with standard-dose warfarin after aortic valve replacement with the On-X mechanical valve.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 21, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said. “Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. The new larger sizes allow us to treat more ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance LivaNova Source Type: news

Venus Medtech launches Venus pulmonary valve implant
Chinese heart valve maker Venus Medtech said today it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region. The Venus P-Valve was designed for percutaneous use in native right ventricular outflow tracts, the Hangzhou-baesd company said, and is intended for patients who wish to avoid sternotomy and cardiopulmonary bypasses associated with traditional valve replacement surgeries. The first procedures were performed on two patients who had previously been treated with surgical patch correction for tetralogy of ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Replacement Heart Valves Venus Medtech Source Type: news

LivaNova wins Japanese nod for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today it won approval from Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve designed to treat aortic valve disease. The London-based company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions. “With this approval for Perceval, an innovative and trusted valve platform, we ar...
Source: Mass Device - June 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves LivaNova Source Type: news

TriCares raises $26m Series B for tricuspid valve program
TriCares said today that it raised nearly $26 million in a Series B round for the tricuspid valve replacement technology it’s developing. Paris- and Munich-based TriCares said the €22 million ($25.8 million) round was led by new backers Wellington Partners, Andera Partners and BioMed Partners, plus existing investors CM-CIC Innovation, CapDecisif Management and GO Capital. Proceeds from the round are slated to go toward product development, clinical trials and a bid for CE Mark approval in the European Union, the company said. “We believe the unique design of our heart valve prostheses will ...
Source: Mass Device - June 4, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat TriCares Source Type: news

Pioneering keyhole procedure that seals leaking heart valves
People left breathless and even housebound by a common heart condition can now benefit from a pioneering keyhole procedure that spares them the ordeal of open surgery (Source: the Mail online | Health)
Source: the Mail online | Health - June 2, 2018 Category: Consumer Health News Source Type: news

Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device. In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the Israel-based company said. “Knowing what we now know about the significant risks of stroke and other neurological injury associated with TAVR and other cardiovascular procedures, there is a clear unmet clinical need for cerebral embolic protection devi...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Neurological Keystone Heart Source Type: news

JC Medical Becoming Serious Challenger in TAVR Fray
Edwards Lifesciences and Medtronic have been at the forefront of the transcatheter aortic valve replacement (TAVR) market for a few years now. However, as time goes on, the two companies are facing increasing competition from a  number of challengers. These companies aren’t necessarily new – but they have passed the test of time to put them on the field of being relevant in the market. The latest company to show margins of success is privately held firm, JC Medical, which was formed in 2009. On Thursday, the Burlingame, CA-based company said it had treated the first patient with the J-Valve TF System ...
Source: MDDI - May 31, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report. Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did not reduce mortality, but was associated with a lowered rate of stroke at 30 days, according to the report. The decline was mainly driven by registry data and was not confirmed by randomized controlled trials, Medscape specified. Stroke was repo...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Claret Medical Inc. Source Type: news

JC Medical touts first-in-human use of transfemoral J-Valve TAVI
JC Medical today announced the first clinical procedure using its transfemoral J-Valve TF transcatheter aortic valve implant system designed to treat aortic regurgitation. The procedure, performed at Vancouver’s St. Paul’s Hospital by Dr. John Webb, marks the first in-human use of the transfemoral TAVI device, the China-based company said. JC Medical’s J-Valve System is designed to restore normal blood flow out of the heart and into the body, which may improve symptoms of heart failure such as shortness of breath, fatigue and chest pain, the company said. The devices feature a proprietary anchor mechanism...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Replacement Heart Valves JC Medical Source Type: news

NOTION: TAVR Still Holds Sway in Low-Risk Patients at 6 Years NOTION: TAVR Still Holds Sway in Low-Risk Patients at 6 Years
Hemodynamic valve performance was superior after TAVR compared with surgical aortic valve replacement, and structural valve deterioration was also significantly lower.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 29, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

EuroPCR 2018 Roundup: Edwards reportedly pauses Centera valve EU launch
Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting. Delivery of the unit and its use in clinical cases are slated to resume during the third quarter, according to the letter, with Edwards claiming there will be no impact on its financial guidance for the year. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized deli...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Edwards Lifesciences Source Type: news

Venus Medtech inks exclusive TriGuard 3 deal with Keystone Heart
Chinese heart valve maker Venus Medtech said yesterday it inked a partnership deal with Keystone Heart through which Venus will gain exclusive rights to develop and sell a third-gen version of Keystone’s TriGuard 3 device in China and other Asian markets. The deal builds on a partnership between the two companies announced last March to promote Venus’ TAVR system, the Venus A-Valve, in combination with Keystone Heart’s 1st-gen TriGuard cerebral embolic protection device in China and other major Asian markets. “Venus Medtech is not solely focused on transcatheter valve products. We care abo...
Source: Mass Device - May 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological Replacement Heart Valves Research & Development Keystone Heart Venus Medtech Source Type: news

Real World Data Could Give Edwards Edge in TAVR
Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR. The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. Nearly 2,000 patients were involved and treated in more than 450 commercial centers around the U....
Source: MDDI - May 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follo...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news

8 companies commercializing transcatheter mitral valve replacements
[Images from Edwards Lifesciences, Highlife Medical and Abbott]Transcatheter mitral valve replacement is a new frontier in the cardio device field, with big legacy medical device companies including Edwards Lifesciences, Medtronic and Abbott spending hundreds of millions of dollars on companies in the space. Much different from transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR) has been mostly experimental. TMVR is used to treat mitral regurgitation, which is a leakage of blood backward through the mitral valve each time the left ventricle closes. According to the American Hea...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiac Implants Cardiovascular Replacement Heart Valves 4cmedical Abbott Boston Scientific Edwards Lifesciences HighLife LivaNova MedTech Medtronic Neovasc Inc. TMVR transcatheter mitral valve replacement Source Type: news

NaviGate touts “ excellent ” valvular function at 1 year with Gate tricuspid valve
NaviGate Cardiac Structures Inc today touted that the first patient to receive its Gate tricuspid valved stent through a transjugular access procedure under compassionate use protocols has reached one year post-procedure and still maintains excellent valvular function. The procedure was performed last April at the Cleveland Clinic, the Lake Forest, Calif.-based company said. At one year, the patients’ bioprosthesis is demonstrating “excellent leaflet mobility and valve function,” NaviGate said. A total of 16 patients have been treated with the valve for severe tricuspid regurgitation, the company sai...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves NaviGate Cardiac Structures Inc Source Type: news

Venus Medtech wins backing from DCP Capital
Chinese heart valve maker Venus Medtech said yesterday it inked a definitive investment agreement with DCP Capital to support the upgrading and internationalization of its valve products. Through the deal, DCP Capital will also support clinical research into a new mitral and tricuspid valve disease treatment technology as the company looks to make a more solid entry into the international heart valve market, Venus Medtech said. “DCP is delighted to have the opportunity to invest into Venus Medtech. We are extremely impressed with the company’s outstanding management team, strong technological cap...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Venus Medtech Source Type: news

CoreMedic launches first-in-human study of ChordArt mitral repair device
German medtech developer CoreMedic this week announced the launch of a first-in-man trial of its ChordArt mitral valve repair device, touting the trial as the first of its kind to treat patients with ruptured or elongated mitral chords. The company’s ChordArt implant is designed to replace ruptured or elongated mitral chordae and to re-establish the connection of the valve leaflets with the papillary muscle to restore functionality. In the trial, researchers will explore the use of the system in up to 40 patients at six European centers, CoreMedic said. “The first clinical use of ChordArt is a major milestone i...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials coremedic Source Type: news

Ancora Takes on FMR and Heart Failure with AccuCinch
Ancora Heart is making a play for the functional mitral regurgitation (FMR) treatment market – which is currently populated by medtech juggernauts Abbott Laboratories and Edwards Lifesciences. The Santa Clara, CA-based company came closer to its goal to participate in the market after it received FDA approval to expand the enrollment for an early feasibility study of the AccuCinch. Ancora Heart said it can now enroll a second group of patients and expand to 15 heart centers across the U.S. “The AccuCinch System is a left ventricular repair technology and it really is a new category and class of therapy,” ...
Source: MDDI - May 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

Neovasc Sales Significantly Down for the Quarter
Neovasc, one of the smaller players in the transcatheter mitral valve replacement (TMVR) space, has seen a huge decrease in revenues, according to results posted in its most recently recorded earnings quarter. The Vancouver-based company said revenues declined by 77% from $339, 922 for the first quarter of 2018 compared to revenues of $1.5 million from the same period in 2017. "Despite a challenging period for our shareholders, we are encouraged by our improved financial position through the receipt of $12.3 million in proceeds from investor-initiated exercises of Series C warrants that were issued during our Nov...
Source: MDDI - May 14, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Implants Source Type: news

#MayoClinicRadio podcast: 5/12/18
Listen: Mayo Clinic Radio 5/12/18 On the Mayo Clinic Radio podcast, Dr. Charanjit Rihal, a cardiologist at Mayo Clinic, discusses aortic valve disease and options for?valve repair and replacement.?Also on the podcast, Dr. Alice Gallo De Moraes, a critical care specialist at Mayo Clinic, explains how Rapid Response Teams help hospitalized patients get critical care [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - May 14, 2018 Category: Databases & Libraries Source Type: news

Study: Researchers create new tissue-engineered valve that mimics the heart
Researchers have created a new prosthetic heart valve intended to closely mimic the functionality and properties of natural heart valves, according to a study posted to Science Translational Medicine. Investigators in the study hope the new valve will help overcome issues that have held back previous tissue-engineered heart valves. The valve, designed from polymer scaffolds seeded with vascular cells and allowed to grow in a bioreactor culture, was decellularized and implanted in a transcatheter procedure in an animal test. Researchers monitored the valve for a year across 11 separate implantations, and found that after 12...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Replacement Heart Valves Research & Development Source Type: news