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Cardiovascular

Corvia Medical closes $54M financing to support atrial shunt

June 9, 2022 By Sean Whooley

Corvia Medical announced today that it closed a $54 million equity financing from its existing investor syndicate. Tewksbury, Massachusetts–based Corvia Medical earmarked the funds to support a confirmatory trial to build upon data and learnings from the clinical trial of its Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced HFmrEF […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Featured, Funding Roundup, News Well, Structural Heart Tagged With: Corvia Medical

Study supports Boston Scientific’s Acurate neo2 aortic valve system

June 8, 2022 By Sean Whooley

New registry data demonstrates positive hemodynamic performance and clinical outcomes with the Boston Scientific (NYSE:BSX) Acurate neo2 TAVI system. Dr. Andrea Scotti of the Montefiore Medical Center (New York) presented data on the current-generation aortic valve system at TVT: The Structural Heart Summit. It was simultaneously published in EuroIntervention. In an investigator-driven study, retrospective registry […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, News Well, Replacement Heart Valves, Structural Heart Tagged With: Boston Scientific, tavr

FDA designates new Medtronic HVAD pump implant recall as Class I

June 8, 2022 By Jim Hammerand

Medtronic (NYSE:MDT) is recalling 1,614 of its HeartWare Ventricular Assist Device (HVAD) pump implant kits due to defective welds connected to at least one death. The Class I recall — the most serious type of FDA recall, in which use of the device may cause serious injuries or death — is the latest of more than 15 […]

Filed Under: Blog, Cardiac Implants, Cardiovascular, Implants, News Well, Recalls, Regulatory/Compliance Tagged With: FDA, Medtronic

Abbott presents positive data on MitraClip, TriClip heart implants

June 8, 2022 By Sean Whooley

Abbott (NYSE:ABT) today announced late-breaking data supporting its MitraClip and TriClip structural heart solutions. Data for the MitraClip transcatheter edge-to-edge repair (TEER) device and the TriClip minimally invasive tricuspid heart valve repair device were presented at TVT: The Structural Heart Summit, the annual meeting from the Cardiovascular Research Foundation in Chicago. The company said in […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Implants, Replacement Heart Valves, Structural Heart Tagged With: Abbott

First patient enrolled in MedAlliance’s drug-eluting balloon trial

June 8, 2022 By Sean Whooley

MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK clinical trial […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Drug-Eluting Stents, Vascular Tagged With: MedAlliance

AtriCure treats first patient in Isolator Synergy clamp trial

June 7, 2022 By Sean Whooley

AtriCure (Nasdaq:ATRC) announced today that it treated the first patient in its HEAL-IST clinical trial in Belgium. Dr. Mark LaMeir and Dr. Carlo de Asmundis treated the first patient in the HEAL-IST trial evaluating the AtriCure Isolator Synergy clamp for treating drug-refractory patients diagnosed with inappropriate sinus tachycardia (IST) at University Hospital Brussels. “Symptomatic IST […]

Filed Under: Cardiovascular, Clinical Trials, Vascular Tagged With: atricure, AtriCure Inc.

What is pulsed-field ablation? Here’s what you need to know

June 3, 2022 By Chris Newmarker

Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston. Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated. PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA […]

Filed Under: Cardiovascular, Catheters, Featured, News Well, Research & Development, Vascular Tagged With: Acutus Medical, Boston Scientific, DeviceTalks Boston, Medtronic, pulsed-field ablation (PFA)

Getinge’s Atrium Medical has a Class I recall over covered stents

June 2, 2022 By Danielle Kirsh

The FDA today determined that Atrium Medical’s recall of some of its iCast covered stents is Class I, the most serious kind. Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the […]

Filed Under: Cardiovascular, Catheters, Featured, News Well, Stents Tagged With: Atrium Medical

Cardio Flow’s FreedomFlow guidewire wins FDA clearance

June 2, 2022 By Danielle Kirsh

Cardio Flow this week won FDA 510(k) clearance for its FreedomFlow peripheral guidewire and announced the first commercial case using the device in the U.S. St. Paul, Minnesota-based Cardio Flow designed FreedomFlow to provide support for diagnostic and therapeutic devices in treating plaque blockages in arteries above and below the knee. It has a stainless […]

Filed Under: 510(k), Cardiovascular, Catheters, News Well, Regulatory/Compliance Tagged With: Cardio Flow

FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter

May 31, 2022 By Sean Whooley

Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]

Filed Under: Cardiovascular, Catheters, Drug-Device Combinations, Featured, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Vascular

Abbott imaging catheter recall flagged as Class I by FDA

May 27, 2022 By Jim Hammerand

The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]

Filed Under: Blog, Cardiovascular, Catheters, Food & Drug Administration (FDA), Imaging, News Well, Recalls, Regulatory/Compliance, Vascular Tagged With: Abbott, FDA

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