Micro Interventional Devices (MID) has completed enrolment in its secure transapical access and closure study (STASIS). STASIS is a non-randomised, multicentre, CE mark study, evaluating the safety and performance of Permaseal, an automated direct myocardial ventricular access and closure technology especially designed for use in transcatheter valve replacement procedures (TAVR and TMVR).
“We are very pleased with the results of the initial 30-day follow up data,” stated Willard Hennemann, MID’s chief science officer. “This is a major milestone for our company as it demonstrates the safety and performance of Permaseal in a clinical setting. It also indicates that Permaseal may offer improved outcomes over the current standard of care.”
Preliminary results indicate that Permaseal shortened operating time and hospital stay, reduced adverse events including the need for transfusion and reduced 30-day mortality and stroke rates to 0%. MID says that the technology provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including TAVR, TMVR, patent foramen ovale, and minimally invasive valve insertions.
“The results of our STASIS study confirmed Permaseal to be a reliable and reproducible myocardial access and closure technology,” said Michael Whitman, president and chief executive officer. “These results are particularly significant given Permaseal’s relative low cost and how quickly surgeons learn to utilise the technology.”
An analysis of the complete 30-day follow up data will be available in the near future.