MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions. MedAlliance received its first IDE for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August. […]
Vascular
Boston Scientific to acquire majority stake in interventional tech developer Acotec
Boston Scientific (NYSE:BSX) announced that it intends to make a partial offer to acquire a majority stake in Acotec. Marlborough, Massachusetts-based Boston Scientific’s offer could add up to a maximum of 65% of Acotec’s shares. Its proposed price totals HK$20 per share. That amounts to approximately $523 million for the 65% stake at current exchange […]
B. Braun buys catheter securement device portfolio from Starboard
B. Braun Medical announced today that it acquired the Clik-FIX catheter securement device portfolio from Starboard Medical. Clik-FIX adds to B.Braun’s offerings that help improve patient experiences and outcomes for peripheral intravenous (IV) therapy. Get the full story at our sister site, MassDevice.
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 (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Medtronic launches Onyx Frontier drug-eluting stent
Medtronic (NYSE:MDT) launched its newest drug-eluting coronary stent, Onyx Frontier. The Fridley, Minnesota-based company designed the Onyx Frontier drug-eluting stent (DES) to build upon its Resolute Onyx DES. It uses the same stent platform as the Resolute Onyx and has an enhanced delivery system to increase acute performance in interventional coronary artery disease procedures. Get […]
First U.S. patient enrolled in MedAlliance Selution SLR drug-eluting balloon trial
MedAlliance announced today that the first U.S. patient was enrolled in a U.S. clinical trial of its novel sirolimus-eluting balloon. Geneva, Switzerland-based MedAlliance received FDA investigational device exemption (IDE) approval for its Selution SLR drug-eluting balloon in the below-the-knee procedures. One week later, the company enrolled the first patient in its multi-center FDA Selution4BTK trial in […]
Study backs Fluidx embolic device for vessel filling
Fluidx Medical announced today that study results support vessel filling with its GPX embolic device when compared to microspheres. Salt Lake City-based Fluidx designed the GPX embolic device for simple preparation and controllable material delivery, packaged ready-to-use in a syringe and capable of being prepped tableside by a clinician in about 30 seconds. It may […]
MedAlliance wins second FDA IDE nod for drug-coated balloon
MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system. The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA). Geneva, Switzerland-based MedAlliance’s second IDE […]
Concept Medical begins enrollment for sirolimus-coated balloon trial
Concept Medical announced today that it has already enrolled 15 patients in a trial of its drug-coated balloon (DCB) for peripheral artery disease (PAD). Tampa, Florida-based Concept Medical’s LIMES prospective multi-center randomized controlled trial to evaluate the safety and efficacy of below-the-knee (BTK) sirolimus drug-coated balloon against standard angioplasty for the treatment of infrapopliteal occlusions […]
Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon
Advanced NanoTherapies announced today that it closed an oversubscribed Series A equity financing round. Los Gatos, California-based Advanced NanoTherapies, which develops the SirPlux Duo drug-coated balloon (DCB) for treating de novo coronary artery disease (CAD) lesions, has now raised $12.5 million in total since September 2020. The company said in a news release that the […]
