Micro Interventional Devices initiates “first-in-man” clinical study of Permaseal

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Micro Interventional Devices has reported the first successful clinical case using its Permaseal Cardiac Access and Closure technology. This new technology simplifies minimally invasive aortic valve replacement procedures. The patient is the first to be enrolled in the Secure Transapical Access and Closure Study (STASIS) being conducted in Europe.

The first STASIS case was performed by Sabine Bleiziffer under the direction of principal investigator Rudiger Lange, director of the Department of Cardiovascular Surgery at The German Heart Center of Munich, Germany. “This elegant and simple device moves us one step closer to a truly percutaneous solution to transapical transcatheter heart valve procedures,” says Bleiziffer.

 


STASIS is a non-randomised, multicentre, CE-mark study evaluating the safety and performance of Permaseal for direct ventricular transapical access and closure. The study is being conducted at six sites within the European Union enrolling 40 patients scheduled for transapical transcatheter aortic valve replacement (TAVI) procedures utilising Edward’s Sapien XT or Sapien 3 Transcatheter Heart Valve.

 


“The completion of the first-in-man procedure is an exciting milestone for our company,” states MID president and chief executive officer Michael Whitman. “The STASIS clinical trial will demonstrate the safety and efficacy of a reliable and easy-to-use left ventricular access and closure device in a minimally invasive structural heart repair procedure. Our ultimate goal is to enable a fully percutaneous left ventricular TAVI procedure.”

 


A reliable, reproducible access and closure technology will shorten the learning curve for surgeons and make the transapical approach applicable to a broader range of TAVI patients. As the transcatheter mitral valve replacement (TMVR) market emerges, Permaseal will facilitate a direct transmyocardial approach to the mitral valve and make this life-saving procedure available to more patients.

 


Willard Hennemann, senior vice president, Clinical Affairs will review Permaseal and provide a preview of data from the STASIS study during PCR London Valves (28–30 September, London, UK).

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