Cardiovascular Systems (NSDQ:CSII) today released 18-month results from the Liberty 360° study of peripheral artery disease interventions, touting high freedom from adverse events and amputations. Results from the study were presented by Dr. William Gray of Wynnewood, Penn.’s Lankenau Heart Institute at the Cardiovascular Research Technologies 2018 interventional cardiology conference in Washington D.C., the St. Paul, […]
Vascular
Endologix launches study of second-gen Nellix endovascular aneurysm sealing system
Endologix (NSDQ:ELGX) said today that the first patient was treated in a study of its Nellix endovascular aneurysm sealing system. The company’s Nellix system, designed to seal a patient’s entire aneurysm, is being developed as an alternative to traditional EVAR devices. Endologix’s system has CE Mark clearance in the European Union and is sold in a […]
FDA clears robotic movement software from Corindus
The FDA granted 510(k) clearance to the first automated robotic movement software designed for Corindus Vascular Robotics (OTC:CVRS) CorPath GRX percutaneous coronary intervention platform, the company reported today. The Rotate on Retract feature allows the person operating the CorPath GRX to navigate to a targeted lesion by automatically turning the guidewire upon joystick retraction. The software […]
Terumo pays at least $20m for Medeon Biodesign’s XPro vascular closure device
Medeon Biodesign (TPEx:6499) said today that it agreed to sell its XPro suture-mediated vascular closure device to Terumo Corp. (TYO:4543) for $20 million up front, plus milestones. The XPro device is designed for vascular closure following transcatheter aortic valve replacement, endovascular aneurysm repair, thoracic endovascular aneurysm repair and percutaneous balloon aortic valvuloplasty procedures. Medeon said it plans […]
LimFlow hopes to give end-stage CLI patients an alternative to amputation with its pDVA system
Earlier this year the FDA accepted LimFlow’s Percutaneous Deep Vein Arterialization system into its Breakthrough Device Program. CEO Dan Rose is hopeful that that designation, along with an increased feasibility study size, will help get the company’s pDVA product to critical limb ischemia patients in the US facing limb amputations with no other options. “There […]
AtriCure beats the Street during Q4, analysts predict ‘growth acceleration’
AtriCure (Nasdaq: ATRC) — an innovator in treatments for atrial fibrillation and left atrial appendage management — is enjoying a rise in its stock value today after releasing results that beat the Street. Mason, Ohio–based AtriCure’s stock was up 67 cents per share, or 3.7%, closing at $18.99. The company reported yesterday evening that it revenue for […]
Abbott, Surmodics ink $25m deal for drug-coated balloon tech
Abbott (NYSE:ABT) is slated to pay $25 million upfront for the global commercialization rights to Surmodics‘ (NSDQ:SRDX) SurVeil drug-coated balloon, the companies announced today. The company’s drug-device combo, which is in pivotal trials in the U.S., is designed to treat peripheral artery disease in the superficial femoral artery. According to the deal, Abbott could also negotiate agreements […]
Medtronic wins FDA nod for smallest drug-eluting stent on U.S. market
Medtronic‘s (NYSE:MDT) 2.0-mm Resolute Onyx drug-eluting stent has won FDA approval and is set to launch in the U.S., making it the smallest device of its kind on the market. The stent is designed to treat patients with coronary artery disease who have small vessels. Interventional cardiologists often face challenges treating this patient group with […]
Reva Medical wins CE Mark for bioresorbable Fantom Encore scaffold
Reva Medical (ASX:RVA) has won CE Mark clearance for its thin strut Fantom Encore bioresorbable, drug-eluting scaffold. The sirolimus-eluting vascular scaffold, which is made from Reva’s Tyrocore polymer, features a 95-micron strut profile and x-ray visibility. Get the full story at our sister site, Drug Delivery Business News.
NaviGate touts implantation for Gate transcath tricuspid valve replacement
NaviGate Cardiac Structures Inc. said today that earlier this month, its catheter-guided Gate valved-stent bioprosthesis became the first orthotopic valve replacement in Canada to treat severe tricuspid regurgitation. The implantation was done at the Quebec Heart and Lung Institute, lead by interventional cardiologists Dr. Josep Rodes-Cabau and Dr. Francois Dagenais. The 79-year-old male patient who […]
FDA clears Access Vascular’s HydroPICC catheter
Access Vascular said today that its HydroPICC catheter has won 510(k) clearance from the FDA. The peripherally-inserted central catheter is designed with Access Vascular’s proprietary bulk-hydrophilic material, which the company touted as “the ideal material for long-term implantable vascular access devices.” “The FDA clearance of the HydroPICC catheter is an important milestone for Access Vascular […]