VASCADE Vascular Closure System Gets FDA PMA (w/video)

Cardiva Medical out of Sunnyvale, CA received FDA Premarket Approval (PMA) for the VASCADE Vascular Closure System, an extravascular device for speedy femoral arterial access site closure. The device is designed to induce hemostasis and close openings, without leaving anything inside the artery, created by size 5F, 6F, or 7F sheaths. It allows for clinicians to re-access the site after closure and is meant to be painless to the patient. From the announcement:Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression, the gold standard for vascular closure for patients undergoing percutaneous procedures through the femoral artery.Read More

Source: Medgadget Anesthesiology - February 11, 2013 Category: Anesthesiology Authors: Gene Ostrovsky Tags: Anesthesiology Radiology Vascular Surgery Source Type: news