Anaconda Biomed announced today that it received CE mark approval to commercialize its ANA5 funnel catheter in Europe. The company designed ANA5, a next-generation funnel catheter, to optimize mechanical thrombectomy. It maximizes clot capture with its vessel-matching diameter funnel. Simultaneously, it enables antegrade flow arrest and offers the … [Read more...] about Anaconda Biomed wins CE mark for funnel catheter
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FDA adds Gradient denervation tech to advisory program
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
Penumbra completes enrollment in pulmonary embolism trial
Penumbra (NYSE:PEN) announced today that it completed enrollment in the STORM-PE trial of its Lightning Flash system. STORM-PE evaluates Lightning Flash computer-assisted vacuum thrombectomy (CAVT) plus anticoagulation. It pits that against anticoagulation alone in the treatment of acute intermediate-high risk pulmonary embolism (PE). The study … [Read more...] about Penumbra completes enrollment in pulmonary embolism trial
FDA expands clearance for Inquis Medical’s Aventus thrombectomy system
Inquis Medical announced today that the FDA granted expanded 510(k) clearance for its Aventus thrombectomy system. The expanded clearance means Aventus now has an indication to treat pulmonary embolism (PE). It comes around a month after the Menlo Park, California–based company shared positive study data for Aventus in PE. The study successfully … [Read more...] about FDA expands clearance for Inquis Medical’s Aventus thrombectomy system
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
Teleflex has positive Arrow catheter data
Teleflex reports new findings from a study showing the efficacy of its Arrow chlorhexidine-impregnated central venous catheters (CVCs). The prospective study cohort included more than 6,670 patients from 12 intensive care units (ICUs). It spanned eight hospitals across India, Malaysia, Papua New Guinea, Colombia, Egypt and Turkey. Wayne, … [Read more...] about Teleflex has positive Arrow catheter data
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
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
BD to begin real-world atherectomy registry for PAD
BD [WtwhTicker symbol="BDX"](NYSE: BDX)[/WtwhTicker] announced today that it plans to initiate a patient data registry for its Rotarex atherectomy system. The registry aims to measure real-world outcomes for patients with peripheral artery disease (PAD). XTRACT, a multi-center, single-arm, post-market registry assesses Rotarex's clinical … [Read more...] about BD to begin real-world atherectomy registry for PAD
