Peripheral/Endo

MedAlliance’s SELUTION SLR drug eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval – making it the first limus DEB to be available to US patients

GENEVA, May 30, 2022 /PRNewswire/ — The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted “breakthrough device designation” by the FDA on March 4, 2019 and further in September […]

Vascular Access Experts to Tackle Ultrasound Disinfection Controversy at INS 2022

Presentation will highlight development of recent recommendation for low-level disinfection of transducers used in percutaneous procedures HARTWELL, Ga., May 26, 2022 /PRNewswire/ — A presentation at the upcoming annual meeting of the Infusion Nurses Society (INS) will discuss the recent development of a policy statement favoring low-level disinfection (LLD) as a safe […]

VentureMed Completes Enrollment of FLEX Vessel PrepTM System Randomized Control Trial in Arteriovenous Fistulas

MINNEAPOLIS, May 24, 2022 /PRNewswire/ — VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that it has completed enrollment of a randomized clinical trial (RCT) titled “FLEX Vessel Prep Prior To […]

Upstream Peripheral Technologies Partners with Red One Medical to Facilitate Access of the GoBack Catheter to the VA Health System

TAMPA, Fla.–(BUSINESS WIRE)–Upstream Peripheral Technologies announced today that it has partnered with Red One Medical for the introduction of the GoBack® Crossing and Reentry Catheter to the VA Health System. The partnership will allow physicians in the VA Health System to have access to this new technology in treating patients […]

United Therapeutics Announces FDA Approval of Tyvaso DPI™

First approval of a dry powder inhaler for treatment of PAH and PH-ILD DPI device represents a convenient option for administration of treprostinil therapy Commercial launch activities underway; patient availability expected in June 2022 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit […]

New Data From Two Large Studies Reinforce Effectiveness of Dual Pathway Inhibition (DPI) with XARELTO® (rivaroxaban) Plus Aspirin in Patients with Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD)

COMPASS open label extension study results support the long-term use of XARELTO® plus aspirin for vascular protection in patients with chronic CAD and/or PAD XATOA registry provides further evidence of the benefit of DPI for CAD and/or PAD patients at high risk of cardiovascular (CV) events RARITAN, N.J., May 23, 2022 /PRNewswire/ — Findings from […]

Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy

Approvals Cover Both Coronary and Peripheral IVL Catheters and Generators Manufactured by Shockwave SANTA CLARA, Calif. and SINGAPORE, May 23, 2022 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that […]

VenoStent Technology Receives Breakthrough Device Designation by FDA

HOUSTON, TX / ACCESSWIRE / May 17, 2022 / VenoStent, Inc., a clinical-stage tissue engineering company developing bioabsorbable perivascular wraps to improve outcomes in the 5 million vascular surgeries performed each year, announces that The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has granted […]

Centerline Biomedical Announces Successful Structural Heart Animal Study

Centerline Biomedical executes animal study demonstrating 4D augmented reality navigation through complex structures of the heart CLEVELAND , May 19, 2022 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline) announced Thursday the completion of the second in a series of structural heart navigation animal studies. Physicians from Cleveland Clinic’s top-ranked Heart, Vascular and Thoracic Institute […]