Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.
Keeping you up to date on recent developments in cardiology, including: Fibroblast growth factor a marker for left ventricular hypertrophy in dialysis patients; Consortium updates endpoints for aortic valve studies; ‘Reclip,’ surgery square off for patients with failed mitral valve repair.
PARIS – Imageens SAS just raised a $1.4 million seed round to develop its two artificial intelligence (AI) systems in the field of medical imaging in Europe. Its first solution Artfun+, an AI software application, makes it possible to anticipate cardiovascular pathology thanks to new prognostic biomarkers. Its second product is Label, an algorithm which automatically classifies and assesses medical imaging data.
Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.
Keeping you up to date on recent developments in cardiology, including: PCI still the treatment of choice for COVID-positive STEMI patients; Utility of risk scores for TAVR patients questioned; Plaque similarly predictive in women and men.
The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.
Endologix LLC said Tuesday that it has completed the acquisition of Pq Bypass Inc., a privately held company developing a novel technology for treating severe peripheral artery disease (PAD). Pq Bypass’ Detour system is currently being studied in a U.S. and European clinical trial, DETOUR2.
Keeping you up to date on recent developments in cardiology, including: Rheumatic aortic stenosis responds well to TAVR vs. SAVR; Cardiac MR may improve correct diagnosis of left ventricular non-compaction; Better management needed for infarct patients with mechanical complications.
Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology. The company’s goal is to take the medical devices that have been used most ubiquitously throughout medicine, one by one, and replace them with smart technologies that incorporate such things as software, sensors and signals technologies.
PARIS – Holistick Medical SAS reported a $5 million round for development of the first generation of a light-activated implant for a patent foramen ovale (PFO). Truffle Capital provided the startup with $4.6 million, while Bpifrance provided $470,000 in non-dilutive funding. “This robust financing provides us with the resources needed to catapult our strategy forward and reinvent the treatment of heart defects such as PFO, which can be associated with occurrence of stroke in young people,” Boris Warnack, CEO of Paris-based Holistick Medical, told BioWorld.
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