Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to enroll up to 335 subjects at […]
Structural Heart
Cardiac Dimensions raises $53M for mitral contour system
Cardiac Dimensions announced today that it closed an oversubscribed Series E financing round worth $53 million. Ally Bridge Group led the Series E round, while new investor Claret Capital Partners joined in. Existing investors also provided significant participation. That list includes Hostplus, M.H. Carnegie, Horizon 3 Healthcare, Lumira Ventures and a confidential strategic investor. The […]
Laplace Interventional raises $22M for tricuspid valve tech
Laplace Interventional announced today that it completed a Series C financing round to support its prosthetic heart valve technology. An undisclosed global strategic investor led the financing round. New investors Aphelion Cardeation and Unorthodox Ventures joined in the Series C as well. The Minnapolis-based company also picked up funds from existing investors Engage Venture Partners, […]
Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
Second Heart Assist today announced data from a study highlighting the performance of its Whisper device against a competitive heart pump. The study showed that Whisper — a next-generation percutaneous mechanical circulatory support (pMCS) system — caused significantly less hemolysis than the widely used Johnson & Johnson MedTech/Abiomed Impella CP when both pumps were operated […]
First patient enrolled in Merit Medical occluder system study
Merit Medical Systems (Nasdaq:MMSI) announced today that investigators enrolled the first patient in a study of its Bloom micro occluder system. The PREEMIE study evaluates the Bloom system for treating patent ductus arteriosus (PDA) in premature infants. A hemodynamically significant or large PDA (hsPDA) can negatively affect a baby’s health and require treatment. According to […]
Medtronic has positive TAVR results in small aortic annulus patients
Medtronic released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli. The SMART trial assessed patients with aortic stenosis and a small aortic annulus. At two years, the study found comparable composite outcomes, including mortality, disabling stroke and heart failure hospitalization between Medtronic’s Evolut […]
Reflow Medical expands global reach with European subsidiary
Reflow Medical announced today that it opened a European subsidiary in Landsberg am Lech, Germany, to expand outside the U.S. The company said its strategic expansion strengthens its international presence and enhances its ability to serve markets globally. SVP and GM Knut Saurteig leads the subsidiary, called Reflow Medical Europe GmbH. Under his leadership, the […]
Capstan Medical completes first robot-assisted transcatheter mitral valve replacements
Capstan Medical today announced the first successful transcatheter mitral valve replacements using its novel implant and surgical robotics system. Santa Cruz, California–based Capstan Medical said it’s the first time a minimally invasive robotic structural heart platform has been used in clinical practice. “Today marks a pivotal moment in the evolution of structural heart therapy,” Capstan […]
Medtronic launches extravascular defibrillator in Japan
Medtronic announced that it launched its Aurora EV-ICD system for treating ventricular arrhythmias in Japan. The company’s Japan unit began rollouts for the Aurora EV-ICD MRI device and the Epsila EV MRI lead. They comprise the implantable cardioverter defibrillator (ICD) system that performs electrotherapy to restore a heart to a normal rhythm. Aurora delivers defibrillation, […]
4C Medical secures $175M funding round led by Boston Scientific to support TMVR tech
4C Medical Technologies announced today that it closed a Series D financing round resulting in gross proceeds of up to $175 million. Boston Scientific led the financing round for the heart valve replacement technology developer. Certain new and existing shareholders also participated in the financing. Minneapolis-based 4C Medical Technologies plans to use the funds to […]
Philips discontinues Tack endovascular system sales after serious recall
The FDA has deemed a recall of the Philips Tack endovascular system Class I, the most serious kind. This recall involves removing devices from use and sale. According to the FDA notice, the device may cause serious injury of death if customers continue to use it. As a result of the recall, Philips plans to […]
