Essential Medical gets FDA approval for vascular closure trial

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Medical device company Essential Medical has received FDA approval to conduct a clinical trial to study the safety and efficacy of vascular access closures done using its device branded MANTA.

The Malvern, Pennsylvania-based company will study how well MANTA closes femoral arterial access sites in patients undergoing procedures, it said in a statement today. The device is designed to reduce drawbacks like extended procedure time and higher costs.

"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 EU data,” said Zvonimir Krajcer, co-principal investigator on the trial. “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."

These types of procedures are the fastest growing segment of the cardiovascular market. This submarket alone is expected to exceed $600 million with the next five years, according to Essential.