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 […]
V-Wave lands CE Mark for heart-failure device
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 […]
V-Wave’s interatrial shunt lands another breakthrough nod from FDA
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 […]
V-Wave wins breakthrough nod for heart failure device
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 […]
HydroCision names Tranchemontagne as CEO | Personnel Moves – March 12, 2019
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 […]
V-Wave launches pivotal interatrial shunt trial
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 […]
V-Wave closes $70 million Series C
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. […]
V-Wave touts 1st-in-human for interatrial shunt
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 […]
J&J joins Edwards in $28m Series B for arterial shunt dev V-Wave
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 […]
