LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI). Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition. France-based … [Read more...] about FDA approves LimFlow chronic limb-threatening ischemia treatment
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J&J used RWE for expanded indications — and you can, too
Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions. Real-world evidence (RWE) took a big step forward recently when the FDA approved expanded indications for Johnson & Johnson MedTech ablation catheters. For the first time, the federal medical device safety regulator … [Read more...] about J&J used RWE for expanded indications — and you can, too
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
Route 92 Medical wins FDA clearance for stroke treatment system
Route 92 Medical announced that it received FDA 510(k) clearance for its FreeClimb 70 reperfusion system for treating ischemic stroke. San Mateo, California-based Route 92 designed the reperfusion system with the FreeClimb 70 aspiration catheter. It also features a Tenzing 7 delivery catheter. The system enables physicians to treat patients … [Read more...] about Route 92 Medical wins FDA clearance for stroke treatment system
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4
FDA clears first device authorized under Safer Technologies Program
The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency's Safer Technologies Program. FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of … [Read more...] about FDA clears first device authorized under Safer Technologies Program
FDA clears Lightning Flash thrombectomy system from Penumbra
Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system. Alameda, California-based Penumbra also initiated the launch for the system. The company called Lightning Flash "the most advanced and powerful mechanical thrombectomy system on the market." Lightning Flash features the … [Read more...] about FDA clears Lightning Flash thrombectomy system from Penumbra
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions … [Read more...] about FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic's In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral … [Read more...] about FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
