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V-Wave

15 heart devices that could boost their manufacturers’ sales

May 22, 2020 By Nancy Crotti

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Clinical Trials, Featured, Food & Drug Administration (FDA), Hospital Care, Implants, Regulatory/Compliance, Replacement Heart Valves, Stent Grafts, Stents, Structural Heart, Wall Street Beat Tagged With: Abbott, Aris CV, Cardiofocus, cardiovalve, CE Mark, CryoLife, endospan, FDA, Medtronic, Terumo Aortic, V-Wave

V-Wave lands CE Mark for heart-failure device

March 5, 2020 By Nancy Crotti

V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark. The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who […]

Filed Under: Cardiovascular, Featured, Regulatory/Compliance Tagged With: CE Mark, V-Wave

V-Wave’s interatrial shunt lands another breakthrough nod from FDA

September 13, 2019 By Sean Whooley

V-Wave said yesterday that it won FDA breakthrough device designation for its interatrial shunt for pulmonary arterial hypertension, marking the second time in less than a month that the company has earned a breakthrough nod. The PAH shunt is designed to be placed in the heart through a catheter inserted via a vein in the […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, V-Wave

V-Wave wins breakthrough nod for heart failure device

August 15, 2019 By Nancy Crotti

V-Wave said today that the FDA has granted breakthrough device designation for its interatrial shunt for heart failure (HF). The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced […]

Filed Under: Cardiac Implants, Featured, Food & Drug Administration (FDA), Implants, News Well, Regulatory/Compliance, Research & Development Tagged With: FDA, V-Wave

HydroCision names Tranchemontagne as CEO | Personnel Moves – March 12, 2019

March 12, 2019 By Fink Densford

HydroCision said early this month that it tapped former Smith & Nephew (NYSE:SNN) exec Alain Tranchemontagne as its new chief executive officer. Prior to joining Boston-based HydroCision, Tranchemontagne held a position as U.S. business commercial development senior VP at Smith & Nephew. Before joining Smith & Nephew, Tranchemontagne also held positions at Covidien in senior marketing roles […]

Filed Under: Business/Financial News Tagged With: Aethlon Medical Inc., camberspine, Humacyte, HydroCision Inc., Invictus Medical, IRRAS, Johnson and Johnson, MediWounds, qureai, Senseonics, Smith & Nephew, SynCardia, V-Wave, Virta Health

V-Wave launches pivotal interatrial shunt trial

October 3, 2018 By Fink Densford

V-Wave said today it launched a new trial of its minimally invasive interartrial shunt designed to treat patients with symptomatic heart failure. The new Relieve-HF trial aims to enroll 500 patients in a pivotal study of the device, which is designed for patients with NHYA Class III and ambulatory Class IV symptomatic heart failure, the Israel-based […]

Filed Under: Cardiovascular, Clinical Trials, Vascular Tagged With: V-Wave

V-Wave closes $70 million Series C

April 26, 2018 By Fink Densford

V-Wave said today it raised $70 million in a closed Series C round of financing, with funds slated to support the launch of a pivotal trial of its investigational interatrial shunt device designed for patients with advanced heart failure. The interatrial shunt is designed to be implanted trans-venously and placed in the atrial septum, the Israel-based company said. […]

Filed Under: Business/Financial News, Stents, Vascular, Wall Street Beat Tagged With: Edwards Lifesciences, Johnson and Johnson, V-Wave

V-Wave touts 1st-in-human for interatrial shunt

March 28, 2016 By Fink Densford

V-Wave today released results from the 1st-in-human implantation of its investigational interatrial shunt device designed for patients with advanced heart failure, touting a 100% success rate for implantation and no device-related adverse events. The interatrial shunt is designed to be implanted trans-venously and placed in the atrial septum, where a valve regulates left to right shunting of […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials Tagged With: V-Wave

J&J joins Edwards in $28m Series B for arterial shunt dev V-Wave

January 12, 2016 By Fink Densford

Johnson & Johnson (NYSE:JNJ) joined previous investor Edwards Lifesciences (NYSE:EW) in a $28 million Series B round to support heart failure treating interarterial shunt maker V-Wave, according to a press release posted yesterday. Other groups joining the round included newly-invested TriVentures, Pura Vida Investments and BioStar Ventures, with returning investors Pontifax and the BRM group. “With the […]

Filed Under: Blood Management, Business/Financial News, Cardiac Implants, Cardiovascular Tagged With: V-Wave

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