Essential Medical launches Manta device trial

Essential Medical said today it launched a clinical study of its Manta large bore vascular closure device.

The Manta system is designed to close large bore punctures following procedures like transcatheter aortic valve replacements, abdominal aortic aneurysm repairs and balloon aortic valvuplasty, the Malvern, Penn.-based company said. Essential Medical said the device is designed to close punctures in less than 1 minute and provides immediate hemostasis.

The study will examine patients treated with the Manta device following TAVR procedures, the company said. In initial patients, the Manta device was deployed in less than 1 minute and so far, none of the patients have experienced any complications associated with the device, Essential Medical said.

Initial patients in the study were treated by Dr. Nicholas Van Mieghem of the Erasmus Medical Center and Dr. Antonio Colombo of the San Raffaele Scientific Institute and Columbus Hospital, the company said.

“The deployment of the devices was flawless, and both clinicians found the Manta to be intuitive, easy-to-use and efficacious. Including our 1st-in-man studies, we have now enrolled 19 patients to date with rapid hemostasis and no major complications.  We look forward to enrolling other centers in Hamburg and Vancouver shortly,” CMO Dr. Gary Roubin said in a press release.

Essential Medical also said it enrolled 23 patients in a 50-patient post-market-follow-up study of its X-Seal device, designed to close smaller bore puncture wounds than the Manta. The company said commercialization of the X-seal with a strategic partner is slated to commence following the completion of the study.

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