US-based Micro Interventional Devices (MID) has completed enrollment in the CE mark trial, its Secure Transapical Access and Closure Study (STASIS).
STASIS is a non-randomized and multi-center trial, which will assess the safety and performance of Permaseal, an automated direct myocardial ventricular access and closure technology, specifically designed for use in transcatheter valve replacement procedures (TAVR and TMVR).
Micro Interventional Devices chief science officer Willard Hennemann said: "This is a major milestone for our company as it demonstrates the safety and performance of Permaseal in a clinical setting."
The technology is said to offer a direct access and closure site for emerging complex structural heart disease procedures, comprising TAVR, TMVR, PFO, and minimally invasive valve insertions.
According to the company, preliminary results indicate that Permaseal shortened operating time and hospital stay, decreased adverse events including the need for transfusion and reduced 30-day mortality and stroke rates to 0%.
Micro Interventional Devices president and CEO Michael Whitman said: "The results of our STASIS study confirmed Permaseal to be a reliable and reproducible myocardial access and closure technology."
The company develops and markets technologies for cardiovascular and general surgery