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Source: Mass Device
Procedure: Heart Valve Surgery
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Total 66 results found since Jan 2013.
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.
The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.
Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.
Patients, treated between September 22, 2014...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis.
Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail.
The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation.
Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news
Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said.
The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news
Boston Scientific touts Acurate Neo2 CE Mark study
Boston Scientific (NYSE:BSX) yesterday touted results from a European study of the Acurate Neo2 replacement heart valve it acquired along with Symetis last year.
Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said.
Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause mortality (the p...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news
FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System.
Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2.
The TAH-t system is designed to function as a bridge to a heart transplant...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia 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 a New Technology Add...
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
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 Sentinel d...
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
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
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
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 follow pa...
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
Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures.
The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commercialization, ...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news
Mitralign raises $10m
Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million.
The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016.
The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce v...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Mitralign Inc. Source Type: news
Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said.
“With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
