Forge Medical’s VasoStat Hemostasis Device Cleared for Pedal and Tibial Applications
January 7, 2016—Forge Medical, Inc. announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for expanded indications of the company’s VasoStat hemostasis device to include pedal and tibial hemostasis. VasoStat was previously cleared for radial artery and dialysis access hemostasis.
VasoStat is sold in the United States through National Medical Sales LLC, a United States distributor of interventional and vascular specialty products. In Japan, the device is marketed by Cosmotec, a Japanese distributor of specialty cardiovascular devices.
Timothy W.I. Clark, MD, who is Cofounder and CEO of Forge Medical, is Associate Professor of Clinical Radiology at the University of Pennsylvania Perelman School of Medicine, Division of Interventional Radiology, Department of Radiology, and is the Director of Interventional Radiology at Penn Presbyterian Medical Center in Philadelphia, Pennsylvania.
In the company’s announcement, Dr. Clark commented, “We are proud to provide an innovative hemostasis device for radial artery and dialysis access applications unique from current band-type devices on the market. The FDA clearance for the VasoStat for pedal and tibial hemostasis enables Forge Medical to provide an effective hemostasis solution for physicians who perform retrograde tibial access during lower extremity revascularization procedures for patients with peripheral arterial disease. We see these expanded indications a testament to the safety and utility of the next-generation VasoStat device, which now features a clear window for continuous puncture site visualization and improved ease of application.”