Peripheral/Endo

Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease (SFA)

TAMPA, Fla., May 29, 2023 /PRNewswire/ — The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the Company’s Sirolimus coated balloon. The Company has already received three […]

Excellent 12-Month Results from SELUTION SFA Trial Presented at JET

GENEVA, May 30, 2023 /PRNewswire/ — 12-month results from the SELUTION SFA trial have been presented at the Japan Endovascular Treatment (JET) Conference in Tokyo. The objective of this study was to assess the safety and efficacy of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the […]

Medinol Partners with CoSo Health to Launch the EluNIR™ Drug-Eluting Stent in the U.S.

CoSo Health to work with U.S. Endovascular and others to reach the U.S. market DENVER, May 30, 2023 /PRNewswire/ — CoSo Health today announced signing a U.S. distribution agreement with Medinol for EluNIR™, a new generation, thin-strut drug-eluting stent (DES). Medinol is a global leader in the development of innovative implantable medical […]

Shape Memory Medical Announces Publication of Study Results in Vascular

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced the publication of results from the Company’s prospective, open-label, single-arm, safety study of the IMPEDE Embolization Plug in peripheral vascular embolization. The study was published this month in the peer-reviewed journal, Vascular, ahead […]

Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system

SHANGHAI, May 26, 2023 /PRNewswire/ — Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation. Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. Pulse Medical has been […]

Endologix Announces 150th Patient Enrolled in JAGUAR Randomized Controlled Trial

JAGUAR Study Evaluates ALTO® Compared to Other Commercially Available EVAR Devices IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company, dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced the completion of the 150th case in the JAGUAR Study. This randomized controlled trial […]

Microbot Medical Achieved 100% Success Rate for LIBERTY in Extensive Pre-Clinical Animal Study Performed by Leading European Physicians

A team of six leading European interventional radiologists used the LIBERTY® Surgical Robotic System and performed a total of 48 catheterizations HINGHAM, Mass., May 22, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Surgical Robotic System, the first single-use endovascular robotic system, today announced a […]

Inari Medical Announces PEERLESS II, a Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever® System vs. Anticoagulation in Pulmonary Embolism Patients

IRVINE, Calif., May 22, 2023 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced planned enrollment of the PEERLESS II trial, Inari’s third randomized controlled trial (RCT) in […]

Shockwave Medical Launches New Coronary IVL Catheter Internationally and Enrolls First Patient in All-Female Empower Study

Shockwave C2+ Catheter Expands Utility of IVL in Calcified Coronary Arteries SANTA CLARA, Calif., May 15, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today announced the full commercial availability of the Shockwave C2+ Coronary […]