Forge Medical has announced receiving 510(k) clearance from the US FDA for expanded indications of the device to include pedal and tibial haemostasis. The VasoStat was previously cleared for radial artery and dialysis access haemostasis.
Timothy WI Clark, cofounder and CEO of Forge Medical, said: “We are proud to provide an innovative haemostasis 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 haemostasis enables Forge Medical to provide an effective haemostasis solution for physicians who perform retrograde tibial access during lower extremity revascularisation 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 visualisation and improved ease of application.”
The VasoStat haemostasis device is sold throughout the US through National Medical Sales LLC, a United States distributor of interventional and vascular specialty products, and throughout Japan by Cosmotec, a Japanese distributor of specialty cardiovascular devices.
Clark is associate professor of Clinical Radiology, University of Pennsylvania Perelman School of Medicine, Division of Interventional Radiology, Department of Radiology, and director of Interventional Radiology, Penn Presbyterian Medical Center, Philadelphia, USA.