Tales from TCT 2019: Ancora ’s Heart Felt Data
A stronger and more experienced Ancora Heart entered into the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation this past week. The private company – which is poised to take on medtech giants Abbott Laboratories and Edwards Lifesciences in the functional mitral regurgitation (FMR) space, presented even more data than it did last year at TCT.
“There’s a big presence for us this year [at TCT] with three different presentations,†Jeff Closs, president and CEO of Ancora Heart, to...
Source: MDDI - September 30, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
New Data Demonstrate Strong Outcomes for Abbott Device to Repair Leaky Tricuspid Heart Valves
- New data presented at TCT 2019 on Abbott's TriClip device from the TRILUMINATE Feasibility Study met both the primary safety and performance endpoints (Source: Abbott.com)
Source: Abbott.com - September 28, 2019 Category: Pharmaceuticals Source Type: news
Medtronic Wins Nod for TAVR System Ahead of TCT 2019
Medtronic has won a nod from FDA for the Evolut PRO+ TAVR System – a next-generation transcatheter aortic valve replacement system. The agency’s approval of the device comes just a few days before – TCT 2019.
Plans call for the Dublin-based company to launch the product, which builds off the self-expanding, supra-annular Evolut TAVR platform. The Evolut PRO+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23, 26- and 29-mm valves can treat vessels down to 5.0 mm).
Evolut PRO+ features four-valve sizes â...
Source: MDDI - September 24, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Abbott ’s Pediatric Cardiovascular Devices Gain CE Mark
Abbott Laboratories is bringing two of its pediatric devices in the cardiology space to Europe. The Abbott Park, IL-based company has received CE mark for both the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder.
The Masters valve is the world's smallest mechanical heart valve and allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. Until Abbott's device, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, which could result in improper fit and complications. The Masters pediat...
Source: MDDI - September 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial
Abbott Laboratories’ latest pivotal trial will have the company taking a deeper dive into the treatment of what has been dubbed by some as the “forgotten valve.â€
The Abbott Park, IL-based has launched an IDE study of the TriClip, a transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR).
The TRILUMINATE Pivotal trial will evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve doesn't close properly, allowing blood to flow backward into the heart, which ...
Source: MDDI - September 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Abbott Launches World's First Pivotal Trial to Test New Approach for Repairing Leaky Tricuspid Heart Valves
- TRILUMINATE Pivotal trial is the world's first randomized clinical trial to evaluate transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation (Source: Abbott.com)
Source: Abbott.com - September 5, 2019 Category: Pharmaceuticals Source Type: news
Heart Surgery Long-Term Mortality Rate Higher for Women Heart Surgery Long-Term Mortality Rate Higher for Women
Women have worse long-term mortality after coronary-artery bypass grafting (CABG) and combined CABG/mitral-valve surgery, while mortality risk factors are different for men and women, according to new findings.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - September 3, 2019 Category: Surgery Tags: General Surgery News Source Type: news
Fully Retrievable Valve Shows Promise for TAVR Fully Retrievable Valve Shows Promise for TAVR
The fully retrievable HLT Meridian valve appears safe and effective for transcatheter aortic-valve replacement (TAVR), according to results from the multicenter RADIANT trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 23, 2019 Category: Consumer Health News Tags: Cardiology News Source Type: news
Burst Balloons Prompt Edwards to Recall Sapien 3 Ultra Delivery System
Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to recall 1,585 Sapien 3 Ultra delivery systems from the U.S. market. The company initiated the recall in July but FDA just issued the associated safety alert on Thursday.
The incidents of burst balloons during implantation procedures have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or the need for surgical intervention. The issue has resulted in 17 injuries and one death, ...
Source: MDDI - August 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
Burst Balloons Prompt Edwards to Add Warning to Sapien 3 Ultra Delivery Instructions
Reports of balloons bursting during transcatheter aortic valve replacement (TAVR) implantation procedures prompted Edwards Lifesciences to issue a field safety notice in July with instructions for physicians who treat patients with the Sapien 3 Ultra valve.
FDA issued this safety alert on Aug. 22 calling the action a recall. However, an Edwards spokesperson told MD+DI that the device is not actually being pulled from the market and no devices are being returned as part of this action.
The reported incidents of burst balloons during implantation procedures have resulted in significant dif...
Source: MDDI - August 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
FDA Slaps Class I Recall on Sapien 3 Ultra for TAVR FDA Slaps Class I Recall on Sapien 3 Ultra for TAVR
The class I recall of the transcatheter aortic valve replacement (TAVR) device follows an urgent field warning about burst balloons issued last month by device maker, Edwards Lifesciences.News Alerts (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 22, 2019 Category: Cardiology Tags: Cardiology News Alert Source Type: news
New Expanded Indication Could Change the TAVR Narrative
The transcatheter aortic valve replacement market received one of the biggest jolts of the year when FDA expanded indications of both Edwards Lifesciences and Medtronic’s valves.
FDA’s measure would open up the valves to be used in younger and low-risk patients. The agency said these transcatheter valves – Edwards’ Sapien 3, and Sapien 3 Ultra, with Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications duri...
Source: MDDI - August 19, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news
Today, FDA became the first medical products regulatory body in the world to approve an expanded indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery: https://go.usa.gov/xVCnx pic.twitter.com/i4Y0jh52Xh
Today, FDA became the first medical products regulatory body in the world to approve an expanded indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery: https://go.usa.gov/xVCnx pic.twitter.com/i4Y0jh52Xh (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 16, 2019 Category: Medical Devices Authors: ( at FDAMedia) Source Type: news
Your Medtech Download List
We've put together a list of the latest how-to medtech whitepapers and Webcasts available from Qmed. You’ll find expertise on catheter technologies for TAVR procedures, EU Medical Device Regulations, biomaterials, electroplating, and more.
We also share news on upcoming educational offerings at upcoming MD&M and BIOMEDevice events.
If you’re looking for education on a topic you don’t see, please feel free to let us know at daphne.allen@ubm.com. We welcome suggestions from our medtech community.
Whitepapers
Repairing the Heart With...
Source: MDDI - August 7, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Materials Source Type: news
How 2019 Will Define TAVR for Years to Come
There have been some pretty significant developments in the transcatheter aortic valve replacement market over the past few months. It’s safe to say it’s not going to be business as usual for TAVR in the coming years.
One of the biggest developments in the market was FDA’s approval of Boston Scientific’s Lotus Edge valve in April. The approval did not come as a shock as the Marlborough, MA-based company communicated in August of 2018 that the nod from FDA would come near the middle of 2019.
The approval was truly a game-changer because it meant there w...
Source: MDDI - August 6, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
