Essential Medical received an investigational device exemption (IDE) approval from the FDA on Aug. 1 to begin a trial for its X-Seal 6F vascular closure device.
The company expects to enroll 180 patients at 10 to 15 sites in the U.S., Canada and Europe and evaluate the safety and efficacy of the X-Seal 6F device based on complication rate, time-to-hemostasis and time-to-ambulation. The device has received a CE mark in Europe, but it is not available in the U.S.
In July, the FDA approved an investigational device exemption trial for Essential Medical’s Manta large bore closure device. David Wood, MD, and Zvonimir Krajcer, MD, will be the co-primary investigators for that trial, which will examine the safety and efficacy of the Manta device for femoral arterial access sites in patients undergoing percutaneous procedures.
The researchers plan on using the device in transfemoral transcatheter aortic valve replacement, endovascular aortic repair of abdominal aortic aneurysms, ventricular assist devices and balloon aortic valvuloplasty.
Greg Walters and Gary Roubin, MD, PhD, founded Essential Medical in 2010. Walters was formerly the vice president of product development at Kensey Nash Corporation. Roubin, an interventional cardiologist, implanted the first stent in the U.S. and previously consulted for Cook, MedNova and The Medicines Company.