FDA approves new trial of large bore vascular closure; device receives CE Mark

Essential Medical, Inc. announced that it has received Investigational Device Exemption approval from the FDA to begin a U.S. clinical trial of the company’s large bore vascular closure device.

The pivotal study will evaluate the safety and efficacy of vascular access closure using the Manta large bore vascular closure device for femoral arterial access sites in patients undergoing percutaneous procedures using sheaths ranging from 10F to 24F, according to a company press release.

The device will be used to achieve percutaneous closure in a variety of large bore procedures, including transfemoral transcatheter aortic valve replacement, endovascular aortic repair of abdominal aortic aneurysms, ventricular assist devices and balloon aortic valvuloplasty, according to the release.

“We are constantly seeking a safer and more efficient way to replace a patient’s failing heart valve, which is why our ongoing ... 3M TAVR Trial is so important. While transfemoral TAVR has advanced rapidly and can now be safely performed in fully awake patients in less than 30 minutes, the vascular closure method for these cases has not progressed and access site-related complications remain a concern. Safe, reproducible percutaneous large bore closure is needed before transfemoral TAVR can become the default strategy in most patients,” David A. Wood, MD, FRCP, co-principal investigator of the U.S. MANTA trial and a founding member of the Centre for Heart Valve Innovation, Vancouver, Canada, stated in the release.

Previous research has indicated that closure of large bore femoral access sites may be associated with significant increases in time to achieve hemostasis, procedure time, complications and total cost of care, according to the release. The Manta device was designed to utilize novel closure technology and features simple deployment to provide immediate hemostasis to reduce complications and costs associated with large bore closure procedures, according to the release.

Zvonimir Krajcer

“I’m very excited to be a part of the MANTA vascular closure trial as I believe it will deliver fewer complications and faster overall procedure times based on the [European] data,” co-principal investigator Zvonimir Krajcer, MD, co-director of peripheral vascular disease service at Texas Heart Institute, Houston, stated in the release. “Until now, for endovascular aortic repair, [thoracic endovascular aortic/aneurysm repair] and TAVR we had to use the vascular closure devices that were not originally designed for this indication. Finally, for the first time with Manta, we will have the opportunity to use a reliable and simple vascular closure device for large bore sheaths. This device will, in a safer way, advance the treatment of many patients with aortic aneurysmal and valvular heart disease.”

In related news, Essential Medical, Inc. also announced in July that it has received CE Mark approval for the Manta large bore vascular closure device.

“Our experience in the CE Mark clearly showed [the] Manta [device] can change and improve access site management in the field of large-bore interventions. These challenging procedures will become safer and faster with Manta,” Nicolas Van Mieghem, MD, principal investigator in the EU study and medical director of the department of interventional cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands, stated in the release.

Disclosure: Krajcer, Van Mieghem and Wood are investigators on trials of the Manta device.