PercAssist announced today that it successfully completed the first patient treatment in its EUREKA first-in-human clinical study. The study evaluates PercAssist's minimally invasive extravascular platform that provides hemodynamic support for chronic heart failure patients. Principal investigator Dr. Petr Neuzil completed the first case at … [Read more...] about PercAssist treats first patient in heart failure support trial
Balloons
FDA fast-tracks aneurysm stabilization system from Nectero Medical
Nectero Medical announced today that the FDA granted fast track designation to its endovascular aneurysm stabilization treatment (EAST) system. Tempe, Arizona-based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a … [Read more...] about FDA fast-tracks aneurysm stabilization system from Nectero Medical
Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon … [Read more...] about Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
FDA approves POLARx cryoablation system from Boston Scientific
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
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
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
Cook Medical has more hydrophilic PTA balloon catheter options
Cook Medical today announced more sizes and locations for the Advance Serenity hydrophilic PTA balloon catheter product line. It's now possible for U.S. and Canadian interventionalists to use Advance Serenity for below-the-knee and above-the-knee procedures to treat patients with peripheral artery disease (PAD), according to Cook Medical. In … [Read more...] about Cook Medical has more hydrophilic PTA balloon catheter options
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal … [Read more...] about FDA approves Surmodics SurVeil drug-coated balloon
