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Micro Interventional Devices’ Permaseal Moves Closer To Regulatory Approval With Early CE Trial Results

Preliminary 30-day results from the Secure Transapical Access and Closure Study (STASIS) suggest Micro Interventional Devices’ Permaseal device, a transapical access and closure device for structural heart repair, provides safe and effective hemostasis and wound closure after transapical transcatheter aortic valve replacement. The company estimates the worldwide market potential for the device is more than $3 billion annually.

Interim 30-day outcomes for the Secure Transapical Access and Closure Study (STASIS) of Permaseal from Micro Interventional Devices Inc. indicate that the device, composed of a delivery system and an anchor/suture implant, provides safe and effective soft-tissue approximation in cardiovascular applications such as transcatheter aortic valve replacement (TAVR). The primary endpoint of the CE mark trial, which completed enrollment of 33 patients in December, is acute hemostasis upon closure of the apex at the end of a transapical TAVR procedure (no pulsatile bleeding after implant closure). The company now has 30-day follow-up on all study patients. (See Also see "Micro Interventional Devices: Creating A Tool Box For Structural Heart Disease" - In Vivo, 22 June, 2012..)

Besides achieving 100% procedural success, preliminary results show shortened operating time and hospital stay, fewer adverse events (including the need for transfusion), and reduced mortality and stroke rates to 0%,...

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• By Ashley Yeo

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