Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its POLARx cryoablation system. The new system received an indication for the treatment of patients with paroxysmal AFib. It features the POLARx FIT cryoablation balloon catheter. This device enables two balloon sizes (28 mm and … [Read more...] about FDA approves POLARx cryoablation system from Boston Scientific
Acutus expects AcQBlate ablation catheter approval by end of 2023
Acutus Medical (Nasdaq:AFIB) reported positive second-quarter results, with some future plans that got analysts excited. Shares of AFIB rose 0.8% at 68¢ apiece in mid-afternoon trading today. MassDevice's MedTech 100 Index — which includes stocks of the world's largest medical device companies — fell 2.1%. BTIG analysts Marie Thibault and Sam … [Read more...] about Acutus expects AcQBlate ablation catheter approval by end of 2023
Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra … [Read more...] about Orchestra BioMed wins FDA IDE for drug-coated balloon study
J&J’s Biosense Webster launches AFib mapping catheter
Johnson & Johnson's (NYSE: JNJ) Biosense Webster announced today that it launched the Optrell mapping catheter with TrueRef technology. Irvine, California-based Biosense Webster designed Optrell as a high-density diagnostic catheter powered by its Carto 3 system. It features small electrodes arranged in a fixed array formation. These provide … [Read more...] about J&J’s Biosense Webster launches AFib mapping catheter
Onecrea Medical completes first-in-human implants of TAVR system
Onecrea Medical recently announced that it successfully completed first-in-human implants for its transcatheter aortic valve replacement (TAVR) system. The company designed its next-generation TAVR system to treat aortic stenosis. With a unique concave and convex structure, the TAVR system anchors the valve effectively in the aortic annulus. … [Read more...] about Onecrea Medical completes first-in-human implants of TAVR system
Teleflex completes enrollment in percutaneous coronary intervention study
Teleflex (NYSE: TFX) announced today that it completed patient enrollment in its prospective multicenter Ringer PTCA study. Ringer PTCA is one of two clinical studies evaluating Teleflex's novel Ringer perfusion balloon catheter. The trial enrolled patients across seven leading complex percutaneous coronary intervention (PCI) centers in the U.S. … [Read more...] about Teleflex completes enrollment in percutaneous coronary intervention study
FDA approves drug-coated balloon for BPH symptoms from Urotronic
Urotronic announced that the FDA approved its Optilume BPH catheter system for alleviating urinary symptoms caused by BPH. Minneapolis-based Urotronic designed Optilume as a minimally invasive surgical therapy. It combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel. This treats … [Read more...] about FDA approves drug-coated balloon for BPH symptoms from Urotronic
FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk
The FDA issued healthcare providers updated guidance for certain warning language with paclitaxel-coated devices that treat PAD. These peripheral arterial disease (PAD)-treating devices produced data that does not support an excess mortality risk. Specifically, the FDA's guidance eliminates the need for certain warning language in the device … [Read more...] about FDA updates guidance on paclitaxel-coated devices, determines no link to late mortality risk
BioCardia seeks Japanese approval for catheter-based heart failure cell therapy
BioCardia (Nasdaq:BCDA) announced today that it completed the submission of its CardiAMP cell therapy system to Japan’s regulatory authorities. Sunnyvale, California-based BioCardia submitted CardiAMP to Japan’s Pharmaceutical and Medical Device Agency (PMDA). It seeks approval for the indication of ischemic heart failure with reduced ejection … [Read more...] about BioCardia seeks Japanese approval for catheter-based heart failure cell therapy
FDA approves Metavention’s renal denervation for hypertension pivotal IDE study
Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system. Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled … [Read more...] about FDA approves Metavention’s renal denervation for hypertension pivotal IDE study