Malvern’s Essential Medical Completes Successful Vascular Closure Studies

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Essential Medical, Inc., a privately held Malvern medical device company, says it has successfully completed First in Man studies for a revolutionary vascular closure device.

The MANTA large bore vascular closure device is designed to seal large bore femoral punctures after diagnostic and interventional cardiac catheterization procedures. These can help doctors stop the loss of lives from bleeding complications, limit the need for transfusions, cut hospital costs, and improve patient discomfort and disability.

The company announced Nov. 17 18F MANTA devices were safely and effectively deployed in 5 patients with immediate or rapid hemostasis at large bore puncture sites with excellent clinical, angiographic and hemodynamic success. Patients were discharged the following day with no evidence of hematoma. The MANTA devices were deployed in less than one minute in each patient.

The company said the potential worldwide market for vascular closure products is approximately $1 billion.

Cardiologist Dr. Gary Roubin said MANTA promises to be a “truly transformative technology for large bore therapeutic devices.”

Dr. Lawrence Garcia, chief of Interventional Cardiology at St. Elizabeth’s Medical Center in Boston, also participated in the study.

“This device fills a critical unmet need for endovascular procedures in being able to quickly and reliably close large bore catheter channels,” Garcia said.  “This ability, done simply and safely is a major step to full percutaneous procedures in both the cardiac and peripheral markets.”

Greg Walters, Essential Medical CEO, said the firm plans to initiate further studies in early 2015. Walters and Roubin, a coronary and carotid stenting pioneer, founded the firm in 2010.
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Top photo credit: Universitetssykehuset Nord-Norge (UNN) via photopin cc

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