Sanifit to start new clinical development program of SNF472 in End Stage Kidney Disease patients with Peripheral Artery Disease FDA has agreed to key aspects of the clinical program, including the primary endpoint for the single pivotal phase 3 study There are approximately 175,000 and 150,000 ESKD patients with PAD […]
Peripheral/Endo
Penumbra Augments Vascular Franchise with Latest Indigo System Launch and Expands Medical/Scientific Leadership
Launches Indigo® System Lightning™ 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. […]
FDA Grants the Doraya AHF Catheter Breakthrough Designation
NETANYA, Israel, July 14, 2020 /PRNewswire/ — Revamp Medical, a medical device company developing a percutaneous device for the treatment of acute heart failure (AHF), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Doraya™ device. The Doraya is a temporary catheter, placed in the […]
Shockwave Announces Decisions From the U.S. Patent and Trademark Office on Inter Partes Review Proceeding
SANTA CLARA, Calif., July 08, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the company received the initial rulings related to two of the inter partes review (IPR) cases that were initiated by […]
Anteris Technologies to Host TAVR Key Opinion Leader Symposium Moderated by Matt Miksic of Credit Suisse on July 20th, 2020
Next Generation Technologies for the era of TAVR in Younger Low-Risk Patients with Aortic Stenosis BRISBANE, Australia and EAGAN, Minn., July 09, 2020 (GLOBE NEWSWIRE) — Anteris Technologies Limited (ASX:AVR), a structural heart company advancing the DurAVR™ valve, a novel aortic valve replacement solution, announced today that it will host a […]
Medtronic Begins Real-World Post-Market Study of the Valiant Navion Thoracic Stent Graft System in Patients with Thoracic Aortic Dissection
Global “DISSECT-N” Post-Market Study to Broaden Evidence Base for Safety and Effectiveness of Commercially Available Endovascular Repair Technology DUBLIN, July 06, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the start of a prospective, observational, global, multi-center, real-world, post-market study to evaluate the safety and effectiveness of […]
Society for Vascular Surgery (SVS) Issues Guidance on Competence Recommendations for TCAR
New Guidelines Consistent with Silk Road Medical Certification Process SUNNYVALE, Calif., June 30, 2020 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the In-Press release of a clinical competence statement on training and credentialing for TransCarotid […]
Study Demonstrates that AI Technology is Better Predictor of Stroke than Traditional Methods, Elucid Bio Announces
Dr. Brajesh Lal of the University of Maryland Presents Study Data at the Society for Vascular Surgery Conference July 01, 2020 08:30 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Elucid Bio, maker of the FDA-cleared and CE-marked vascuCAP® software, announced today that its novel artificial intelligence (AI) technology demonstrated an over 70 […]
Intact Vascular Announces Positive One-Year Data from TOBA II BTK Clinical Trial in VIVA Late-Breaking Session
Durable Below-the-Knee Vascular Implant for Post-Angioplasty Dissection Repair Demonstrates Sustained Success Saving Limbs WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive one-year results from its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical […]
New data reconfirms long-term safety profile of the Philips Stellarex low-dose Drug-Coated Balloon
June 26, 2020 Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the four-year results from the ILLUMENATE European Randomized Controlled Trial (EU RCT). The Stellarex DCB cohort demonstrated similar all-cause mortality compared with the control arm through four years. This analysis included […]



