Stealthy catheter developer Route 92 Medical, which is developing a catheter to treat stroke, last week said it raised nearly $13 million in an equity round. Founded in 2015, San Mateo, Calif.-based Route 92 won 510(k) clearance from the FDA a year ago for a percutaneous catheter. The company holds U.S. patents for treating acute […]
Catheters
Philips, Medtronic ink deal to integrate Kodex-EPD imaging & nav with Arctic Front Advance
Royal Philips (NYSE:PHG) and Medtronic (NYSE:MDT) inked a deal to integrate the Dutch firm’s Kodex EPD cardiac imaging guidance with Medtronic’s Arctic Front Advance cryoablation catheter. “This integrated solution can guide physicians during the treatment of AF patients with ablation, as they can view detailed, CT-like 3D anatomy, reducing the need for X-ray imaging,” EPD […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
Medtronic launches Solitaire X thrombectomy device in U.S.
Medtronic (NYSE:MDT) said today that it launched its Solitaire X revascularization device intended for treating acute ischemic stroke in the U.S. The Fridley, Minn.-based company’s Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain, restoring blood flow and removing blood clots that cause acute ischemic stroke. The Solitaire X is the company’s […]
FDA: Edward’s select recall of Miller, Fogarty atrioseptostomy caths is Class I
The FDA has classified a select recall of Edwards Lifesciences (NYSE:EW) Miller and Fogarty atrioseptostomy catheters over balloon deflation, fragmentation and detachment issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Miller Balloon catheter […]
Guerbet wins CE Mark for Sequre, Drakon embolization microcaths
Guerbet (EPA:GBT) said today that it won CE Mark approval in the European Union for its Sequre and Drakon microcatheters intended for use in peripheral embolization procedures. The Villepinte, France-based company’s Sequre microcatheter uses flow dynamics to create a fluid barrier designed to deliver treatment to a target vessel to reduce risk of non-target embolization. The […]
Medline Industries buys Namic business from AngioDynamics
Medline Industries will pay $167.5 million to acquire the Namic fluid management business from AngioDynamics (NSDQ:ANGO), the companies announced today. The deal, subject to customary closing conditions, is expected to close in the summer. It will allow Medline to acquire the manifolds, contrast management systems, closed fluid systems, guidewires, disposable transducers and interventional accessories offered […]
More device shortages pegged to sterilization plant shutdown
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
Avinger wins FDA nod for Pantheris SV small vessel atherectomy device
Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system. The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%. The newly cleared device features a […]
Tioga Medical raises $15m to support transcath mitral, tricuspid valve tech
Newly formed Shifamed portfolio company Tioga Medical said today that it closed a $15 million Series A preferred stock financing round to support its transcatheter mitral and tricuspid valve replacement technology. The Campbell, Calif.-based company said that it is developing novel transcatheter valve replacement technology intended to be simpler and less invasive than current mitral and […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]