Front Line Medical recently announced that it expanded the availability of its COBRA-OS aortic occlusion device to meet growing demands. The Ontario, Canada-based company is increasing production of the COBRA-OS (control of bleeding, resuscitation, arterial occlusion system) occluder following patient success rates and expanded interest from … [Read more...] about Front Line Medical expands availability of COBRA-OS arterial occlusion system
Balloons
MicroVention announces first U.S. clinical case using aneurysm flow diverter Fred X
MicroVention today announced that the first U.S. clinical case of its flow diverter Fred X device was performed at Thomas Jefferson University Hospital in Philadelphia. Aliso Viejo, California-based MicroVention received premarket approval for the Fred X device in September. It uses a self-expanding braided nitinol mesh to redirect blood flow … [Read more...] about MicroVention announces first U.S. clinical case using aneurysm flow diverter Fred X
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren't limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices … [Read more...] about The top 10 catheter innovations of 2021
Laborie acquires exclusive license for drug-coated baloon treatment for urethral strictures
Laborie Medical Technologies announced today that it acquired an exclusive license to the Optilume urethral drug-coated balloon (DCB). Portsmouth, New Hampshire-based Laborie purchased a perpetual, exclusive license to Optilume — developed by Urotronic — following FDA approval in December 2021. The DCB platform received CE mark approval for use … [Read more...] about Laborie acquires exclusive license for drug-coated baloon treatment for urethral strictures
Getinge intra-aortic balloon pump recall is Class I
The FDA determined that Getinge's recall of its Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind. Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in … [Read more...] about Getinge intra-aortic balloon pump recall is Class I
Medtronic says study results show alternative spine procedures could reduce opioid use
Medtronic (NYSE: MDT) says a study shows its balloon kyphoplasty (BKP) and vertebroplasty (VP) technology could eliminate opioid use among many with spinal fractures. The medical device giant sponsored a retrospective claims analysis of a large, nationally representative insurance claims database. The results — recently published in Osteoporosis … [Read more...] about Medtronic says study results show alternative spine procedures could reduce opioid use
FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures
Urotronic today announced that it received FDA approval for its Optilume urethral drug-coated balloon for male urethral strictures. Plymouth, Minnesota–based Urotronic designed the paclitaxel-coated balloon to inhibit new scar tissue growth that can occur after endoscopic dilations. Urethral strictures are scars in or around the urethra that can … [Read more...] about FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures
RenovoRx wins FDA clearance for RenovoCath delivery system
RenovoRx today said it received FDA 510(k) clearance for its RenovoCath delivery system. Los Altos, California-based RenovoRx designed the RenovoCath system as the device component for its RenovoGem chemotherapy drug. The combined drug/device RenovoTAMP trans-arterial micro-perfusion therapy is a dual-balloon infusion catheter that delivers … [Read more...] about RenovoRx wins FDA clearance for RenovoCath delivery system
3 pitfalls to consider when creating catheter delivery systems
Multiple components go into a catheter delivery system, with several ways to combine them. An Edwards Lifesciences senior R&D director goes over potential pitfalls. A catheter is a tube that can deliver devices or pharmaceuticals into the body. It is also commonly used for diagnostic purposes. A catheter has a hub or a handle on its end … [Read more...] about 3 pitfalls to consider when creating catheter delivery systems
Design considerations you need to know when making ablation catheters to treat AFib
Catheters are increasingly deploying heart devices in minimally invasive procedures. CardioFocus VP of engineering Jerry Melsky describes the components and design considerations that go into making successful ablation catheters to treat AFib. Atrial fibrillation (AFib) is the most common irregular heart rhythm disorder. If the atria of the … [Read more...] about Design considerations you need to know when making ablation catheters to treat AFib
