Peripheral/Endo

Vascular Therapies Initiates Enrollment in ACCESS 2 Clinical Trial

– ACCESS 2 is a randomized clinical trial evaluating Sirogen for improving hemodialysis AV Fistula outcomes – CRESSKILL, N.J., Aug. 29, 2022 /PRNewswire/ —  Vascular Therapies, Inc. a clinical-stage biopharma company focused on improving vascular access outcomes in patients with kidney disease, today announced that the first patient in the ACCESS 2 […]

Shape Memory Medical Completes Enrollment in the AAA-SHAPE Early Feasibility Study

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral and neurovascular markets, announced the completion of patient enrollment in AAA-SHAPE, the Company’s prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management […]

First US Patient Enrolled in SELUTION SLR IDE Peripheral Study

GENEVA, Switzerland, Aug. 24, 2022 /PRNewswire/ — The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval. “We […]

Boston Scientific Announces Acquisition of Obsidio, Inc.

Company to add novel technology cleared for use in peripheral vasculature to interventional oncology and embolization portfolio MARLBOROUGH, Mass., Aug. 15, 2022 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced the acquisition of Obsidio, Inc., a privately-held company that has developed the Gel Embolic Material (GEM™) technology used for embolization of blood […]

Vascular experts establish Appropriate Use of Intravascular Ultrasound (IVUS) in peripheral interventions

August 12, 2022 First-ever global consensus guidance published in the Journal of the American College of Cardiology: Cardiovascular Interventions Use of IVUS recommended in all phases of lower extremity arterial and venous revascularization procedures to guide clinical decisions The results come ahead of the multi-society roundtable sponsored by SCAI on peripheral IVUS […]

MedAlliance SELUTION SLR Receives Second FDA IDE Approval

GENEVA, Aug. 9, 2022 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION […]

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

The AFX2 System integrates anatomical fixation into aortic endografts with an advanced delivery system to treat patients with abdominal aortic aneurysm (AAA). IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives with innovative interventional treatments for vascular disease, announced that is has received […]

Non-tapered Catheter Success in Critical Limb Ischemia Pedal Artery Access

XO Cross Catheter Platform successfully used in peripheral vascular procedures utilizing pedal artery retrograde access to treat complex Critical Limb Ischemia (CLI) patients. PARK CITY, Utah, Aug. 1, 2022 /PRNewswire/ — Transit Scientific reports multiple successful peripheral vascular procedures with the XO Cross Catheter Platform utilizing pedal retrograde access. The non-tapered 2Fr […]

LIMES Randomised Controlled Trial about Sirolimus Coated Balloon in BTK takes the first Stride: patient enrolment started

Concept Medical Inc., a pioneer in developing drug delivery device platforms for vascular intervention, has announced the initiation of LIMES trial. MÜNSTER, Germany, July 29, 2022 /PRNewswire/ — LIMES (Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of SiroLIMus Drug Coated Balloon versus Standard Angioplasty for the Treatment of Infrapopliteal Occlusions […]