Lightning 12 and Separator 12 Now Indicated for Treatment of PE ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo® Aspiration System, Lightning™ 12. As part of […]
Peripheral/Endo
Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt
Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial […]
INFINITY ANGIOPLASTY BALLOON CATHETER™ Completes First-In-Human PRECISION ANGIOPLASTY™
TOLEDO, Ohio, Nov. 17, 2020 /PRNewswire/ — INFINITY ANGIOPLASTY BALLOON CO., announced today that its innovative PRECISION ANGIOPLASTY™ balloon platform – INFINITY ANGIOPLASTY BALLOON CATHETER™ has successfully completed First-in-Human clinical trial. Recently cleared by the FDA for PTA treatment of peripheral artery disease including: iliac femoral popliteal infra-popliteal arteries for the treatment of […]
TISSIUM Receives FDA Investigational Device Exemption for Vascular Sealant
IDE Approval Clears Path to U.S. Clinical Trial Launch for Vascular Sealant PARIS–(BUSINESS WIRE)–TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, announced today it has received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption application for its vascular sealant. The approval […]
PQ Bypass Releases Positive 24-Month Data from the DETOUR1 Clinical Trial for Percutaneous Femoropopliteal Bypass at VIVA 2020
Promising long-term safety and effectiveness results from PAD population with extremely complex SFA disease MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc, a medical device pioneer bringing new advancements to the treatment of complex peripheral artery disease (PAD), announces promising long-term safety and effectiveness results from 24-month follow-up data from the DETOUR1 Clinical […]
Inari Medical Announces Presentation of Positive 30-Day Follow-Up Results from First Patients in Real World FLASH Registry
IRVINE, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced follow-up results of the first 230 patients enrolled in its FLASH study. FLASH […]
AngioDynamics Announces Presentation of Positive Safety, Efficacy Results from RAPID Outcomes Database
Represents Largest Catheter Based Thromboaspiration Study Completed to Date LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, announced the safety and efficacy results from the Registry of AngioVac* System Procedures In Detail (RAPID) database. Results […]
New Angioplasty System Dilates Calcified & Fibrotic Vessels
Novel angioplasty enhancement system successfully used to restore blood-flow in calcified and fibrous vessels. PARK CITY, Utah, Nov. 12, 2020 /PRNewswire/ — The new FDA cleared XO Score® system was successfully used to dilate multiple challenging fibrotic and calcific lesions in hemodialysis patients with stenotic and occluded fistulas. Dr. Richard Saxon, FSIR and member of […]
The largest controlled clinical study in the world to investigate the use of the MagicTouch PTA sirolimus-coated balloon for the treatment of peripheral arterial disease
ZURICH, November 10, 2020 / PRNewswire / – Concept Medical Inc., a company focused on medical devices for drug delivery in vascular interventions, announced the enrollment of the first patient in the SirPAD clinical study ( Sir olimus in P eripheral A rtery D isease) (Sirolimus in peripheral arterial disease). The SirPAD is the first randomized controlled clinical trial and for all who […]
LimFlow System Demonstrates Excellent Sustained Amputation-free Survival and Wound Healing at One Year in PROMISE I U.S. Study
Twelve-Month Results Presented Today in Late-Breaking Trials Session at Vascular Interventional Advances (VIVA) Conference PARIS–(BUSINESS WIRE)–LimFlow SA, the pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced the presentation of 12-month data from the […]
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