Concept Medical today announced it received FDA investigational device exemption for its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter. The IDE allows the Tampa, Florida-based company to start a clinical study to treat stenotic lesions of arteriovenous fistula (AVF) in the hemodialysis management of chronic renal failure. "This … [Read more...] about Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Catheters
High voltage in the heart: PFA catheter design tips from Biosense Webster
Tushar Sharma at J&J Medtech’s Biosense Webster discusses pulsed-field ablation (PFA) catheter shapes, sensors, electrodes and device design tips.
Biosense Webster’s pulsed-field ablation (PFA) catheter design and development starts in the heart.
That’s where PFA treats atrial fibrillation (AFib) by killing cardiac cells to isolate errant heart signals and prevent them from triggering irregular heartbeats. PFA uses electric fields to permanently open holes in the walls of heart cells … [Read more...] about High voltage in the heart: PFA catheter design tips from Biosense Webster
How Abbott created its next-gen RF ablation system
For Abbott, combining two innovations into one AFib-treating system required manufacturing fine-tuning. The project’s R&D director explains. Pulsed field ablation (PFA) has generated a great deal of buzz for its potential to reduce complications in procedures for treating atrial fibrillation (AFib). But even as Abbott is developing its Volt … [Read more...] about How Abbott created its next-gen RF ablation system
Cook Medical signs distribution agreement with Bentley for BeBack catheter
Cook Medical today announced it signed a U.S. distribution agreement with Bentley for the BeBack catheter. Under the agreement, Cook Medical will assume commercial responsibilities for this Bentley product. “We are excited to welcome Bentley’s BeBack catheter to our peripheral intervention portfolio,” Alec Cerchiari, director of product … [Read more...] about Cook Medical signs distribution agreement with Bentley for BeBack catheter
ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
ProVerum this week announced it completed enrollment in its ProVIDE pivotal clinical trial to evaluate the safety and effectiveness of the ProVee system. The ProVIDE clinical trial is a prospective, multicenter, double-blind controlled study that evaluates the safety, performance, and effectiveness of the ProVee system in patients with lower … [Read more...] about ProVerum completes enrollment in ProVIDE clinical study for ProVee BPH treatment device
Cook Medical’s shorter Liver Access and Biopsy Set wins expanded indication
Cook Medical this week announced its shorter Liver Access and Biopsy Set (LABS) received pediatric indication. LABS was originally intended for use in adults, but was recently FDA cleared for use in adolescents, children and infants. The Bloomington, Indiana-based company designed the device for use in obtaining liver histology samples via … [Read more...] about Cook Medical’s shorter Liver Access and Biopsy Set wins expanded indication
Inari Medical has positive ClotTriever data
Inari Medical (Nasdaq:NARI) announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system. Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum. Results represent the largest prospective, multi-center, two-year … [Read more...] about Inari Medical has positive ClotTriever data
Abbott is launching its latest Navitor TAVI system in the U.S.
Abbott (NYSE:ABT) is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official. In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of … [Read more...] about Abbott is launching its latest Navitor TAVI system in the U.S.
Boston Scientific has positive Agent DCB study results
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue … [Read more...] about Boston Scientific has positive Agent DCB study results
PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device
PulseCath this week announced it received CE mark approval for its iVAC 2L percutaneous mechanical circulatory support device. The iVAC 2L device helps facilitate high-risk percutaneous coronary interventions. PulseCath designed it to pump blood from the left ventricle to the aorta in synchronization with the natural rhythm of the patient's … [Read more...] about PulseCath wins CE mark for iVAC 2L percutaneous mechanical circulatory support device