Medtech titan Medtronic (NYSE:MDT) said today that it launched its In.Pact Admiral drug-coated balloon in Japan. The company won approval and reimbursement for its device last year from the Japanese Ministry of Health, Labor and Welfare for the treatment of peripheral artery disease in the upper leg. Get the full story at our sister site, Drug Delivery Business News.
Conavi Medical touts first investigational use of Novasight hybrid IVUS-OCT system
Conavi Medical yesterday announced the first use of its Novasight hybrid system designed for imaging coronary arteries through both intravascular ultrasound and optical coherence tomography as part of an investigational trial. The system was used in its first procedure under a Health Canada Investigational Testing Authorization at Hamilton General Hospital by study co-investigators Dr. Tej […]
Endologix pushes Nellix release timeline to 2021
Endologix (NSDQ:ELGX) said it doesn’t expect to receive FDA premarket approval for its Nellix 3.5 endovascular sealing system until 2021. The Irvine, Calif.-based company this week updated on its estimated timeline for anticipated FDA approval, saying it expects to land premarket approval for the Nellix stent graft by the first half of 2021. The forecast is […]
J&J’s Cerenovus wins CE Mark for Bravo flow diverter
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said this week it won CE Mark approval in the European Union for its Bravo flow diverter designed to treat intracranial aneurysms. The newly cleared device is designed to divert blood flow from aneurysms to promote healing and reduce the risk of rupture, the company said. The Bravo is Cerenovus’ first flow […]
NuCryo Vascular inks PolarCath distro deal with Lokai Medical
Privately held cryoplasty developer NuCryo Vascular said today it inked a deal with Lokai Medical to distribute its PolarCath balloon dilation system in the US. San Jose, Calif.-based NuCryo Vascular’s PolarCath system is designed to be used in Balloon Cryoplasty procedures to treat peripheral artery disease. The system has FDA approval and is cleared to […]
Hancock Jaffe steps closer to launching Colombian VenoValve trial
Hancock Jaffe Laboratories (NSDQ:HJLI) said today it won approval from Colombia’s Medical Research Committee at Fundación Santa Fe de Bogotá to launch a first-in-human trial of its VenoValve bioprosthetic valve. The Irvine, Calif.-based company’s VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from […]
Cardiovascular Systems touts 2-year Liberty 360 PAD study data
Cardiovascular Systems (NSDQ:CSII) yesterday released two-year results from the Liberty 360 study examining long-term clinical and economic outcomes for peripheral vascular interventions in treating patients with peripheral artery disease. Results from the trial were presented by Dr. Jihad Mustapha of Grand Rapids, Mich.’s Advanced Cardiac & Vascular Amputation Prevention Centers in a late-breaking presentation at the […]
Boston Scientific inks $160m deal for peripheral stent maker Veniti
Boston Scientific (NYSE:BSX) said today it inked a deal worth up to $160 million to acquire stent developer Veniti. Marlborough, Mass.-based Boston Scientific said it currently owns 25% of the company and will pay $108 million in up-front cash for the remaining stake in Veniti, with an additional $52 million on the line in milestone payments […]
Surmodics’ acquisition hits earnings bottom line
Surmodics (NSDQ:SRDX) today posted earnings that beat expectations on Wall Street and adjusted its guidance for the remaining year. The Eden Prairie, Minn. company took an expected hit to earnings due to its $5 million-plus acquisition of Embolitech’s thrombectomy platform. Surmodics posted a net loss of -$2.68 million compared with a profit of $720 million in the […]
NextGen Medical targets clots in large vessels
NexGen Medical Systems announced the successful completion of the first human use of its XCOIL large vessel (18mm) thrombectomy system for the treatment of deep vein thrombosis (DVT). The new device represents an expansion of the company’s 12mm XCOIL system and is designed to rapidly remove blood clots in large vessels, such as the iliac vein. […]
Integer adds radial introducer for patients with smaller arteries
Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark. RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division. The […]
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