Technology | February 07, 2013

FDA Clears Cardiva Medical’s Vascade Vascular Closure System

Cardiva Medical FDA Pre Market Approval Vascade VCS

February 7, 2013 — Cardiva Medical Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the Vascade Vascular Closure System (VCS). 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.

"We are thrilled to receive PMA approval for VASCADE," said Charles Maroney, president and CEO. Maroney continued, "We appreciate the effort of our clinical investigators who worked with us to achieve this important milestone and establish a new third generation closure technology. Cardiva is well positioned to bring this technology to the marketplace to increase patient throughput and provide a safer and more effective alternative to manual compression across the United States."

James Hermiller, M.D. of The Heart Center, Indianapolis, who served as principal investigator for the trial said, "I am extremely pleased with the outstanding clinical performance of Vascade and with the extraordinary contributions by over 65 clinical investigators and their staff at over 20 clinical sites in the U.S. and Australia who facilitated the study. With PMA approval, Vascade will now be available in the U.S. to all physicians who need safe and effective vascular closure."

Frank Zidar, M.D., clinical investigator at The Heart Hospital of Austin commented, "Vascade is a new generation of extravascular closure technology that offers significant advantages over conventional closure devices and manual compression. I am excited to be able to provide Vascade to my patients and to integrate it into my practice."

Vascade, an extravascular closure device, utilizes a unique delivery system based on a proprietary collapsible disc technology that provides temporary hemostasis during the procedure, which eliminates the need for an intra-vascular component. Secure and rapid hemostasis is achieved with Vascade by the deployment of a thrombogenic resorbable collagen patch at the arteriotomy of the femoral artery.

For more information: www.cardivamedical.com

Related Content

Vascular Solutions, Teleflex
Feature | December 07, 2016
December 7, 2016 — Teleflex Inc. and Vascular Solutions Inc.
angioseal, angio-seal, terumo, St. Jude, vascular closure devices
News | Vascular Closure Devices| October 18, 2016
October 18, 2016 — Abbott and St. Jude Medical Inc.
Vivasure Medical, Closure Device, Series C financing
News | Vascular Closure Devices| September 12, 2016
September 12, 2016 — Vivasure Medical announced last week that the company has completed a Series C financing of €16.
nanoparticles, blood clotting, internal bleeding, American Chemical Society study, Erin B. Lavik

Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. Image courtesy of Erin Lavik, Ph.D.

News | Hemostasis Management| August 24, 2016
August 24, 2016 — Whether severe trauma occurs on the battlefield or the highway, saving lives often comes down to...
Rex medical, Closer Vascular Sealing System, VSS, vascular closure, bioresorbable vascular closure device

A close up view of the Rex Medical Closer Vascular Sealing System components.

Technology | Vascular Closure Devices| August 03, 2016
August 3, 2016 — The U.S.
Vivasure Medical, PerQSeal, vascular closure device, CE Mark
News | Vascular Closure Devices| January 18, 2016
Vivasure Medical announced Conformité Européenne (CE) Mark approval of the world’s first fully bioabsorbable...
News | Hemostasis Management| January 06, 2016
The Medicines Company announced Dec. 18 it has entered into a purchase agreement pursuant to which certain subsidiaries...
News | Vascular Closure Devices| December 16, 2015
Scientists at CBSET have presented preclinical evidence that the Manta Large Bore Vascular Closure Device (VCD) from...
platelet-like particles, PLPs, clotting, substitute, Carver, Lyon, NIBIB

Cartoon representation of a deformable platelet-like particle with fibrin nanobodies attached

Feature | Antiplatelet and Anticoagulation Therapies| July 13, 2015
Researchers have created tiny gel particles that can perform the same essential functions as platelets. The particles...
News | March 30, 2015
The Medicines Company announced that the European Commission has granted marketing authorization for two acute care...
Overlay Init