Gradient Denervation Technologies announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. The company expects its acceptance into … [Read more...] about FDA adds Gradient denervation tech to advisory program
Cardiology
Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
Philips today announced the first procedures in Europe with its recently launched VeriSight Pro 3D ICE catheter. Doctors at the German University Medical Center Mainz and Robert Bosch Hospital in Stuttgart completed the first procedures in Europe after the intracardiac echocardiography (ICE) catheter following its launch across the continent last … [Read more...] about Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
Aortyx raises $16M for bioresorbable aortic patch
Aortyx announced today that it brought in $16 million (€13.8 million) to support its bioresorbable aortic patch technology. The company expects the funding to help bring the patch to first-in-human tests within two years. Funding came from Ship2B Ventures, through its BSocial Impact Fund (supported by Banco Sabadell, the EIF, and AXIS), and Clave … [Read more...] about Aortyx raises $16M for bioresorbable aortic patch
Atraverse raises $29.4M for left-heart access device
Atraverse Medical announced today that it closed a $29.4 million follow-on financing round to help accelerate growth. The San Diego-based company secured an oversubscribed seed funding round worth $12.5 million last year. This follow-on funding builds on that round, which helped to obtain FDA 510(k) clearance and begin the early rollout of … [Read more...] about Atraverse raises $29.4M for left-heart access device
Penumbra launches Ruby XL coil system for large vessel embolization
Penumbra (NYSE:PEN) has received FDA clearance and launched its Ruby XL system for embolization procedures. The Alameda, California-based device maker launched the platform as a new option for physicians treating high-flow or large-vessel cases. The Ruby XL system includes three new coils that are compatible with 0.035-inch diagnostic catheters … [Read more...] about Penumbra launches Ruby XL coil system for large vessel embolization
FastWave Medical reports first-in-human use of coronary laser IVL system
FastWave Medical has completed the first human procedures with its Sola coronary laser intravascular lithotripsy system. The company said that these initial procedures marked the start of its multi-center feasibility study evaluating the platform’s safety and performance. [Scott Nelson, FastWave Medical’s co-founder and CEO, will participate in a … [Read more...] about FastWave Medical reports first-in-human use of coronary laser IVL system
Terumo begins limited release of Roadsaver carotid stent following FDA nod
Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System. Roadsaver is a dual-layer micromesh carotid stent designed to reduce embolic risk during carotid artery stenting (CAS) procedures. It is indicated for use in patients with carotid artery stenosis who are at increased … [Read more...] about Terumo begins limited release of Roadsaver carotid stent following FDA nod
CoreMap wins FDA IDE for ablation mapping tech
CoreMap announced that it received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S. The study aims to evaluate the safety and effectiveness of the CoreMap endocardial EP mapping system in patients with AFib. It looks at both persistent AFib and long-standing persistent AFib. The company says … [Read more...] about CoreMap wins FDA IDE for ablation mapping tech
Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
Elixir Medical announced three-year results from a large randomized controlled trial of its DynamX coronary bioadaptor system. The 445-patient BIOADAPTOR trial compares DynamX to the standard of care Medtronic Resolute Onyx drug-eluting stent (DES). It took place across 34 centers in Japan, Europe and New Zealand. Data — shared this week at … [Read more...] about Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
Medtronic announced today that it received CE mark for several expanded indications for its Prevail balloon catheter. The expanded indications for the paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (or drug-coated balloon/DCB) cover the treatment of coronary artery disease (CAD). According to the medtech … [Read more...] about Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
