Micro Interventional Devices has received the CE mark for its Permaseal transapical access and closure device. The device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium. According to a press release, it is the world’s first device using compliant soft-tissue PolyCor anchor technology.
The press release reports that Permaseal was validated in the STASIS Clinical Study (Secure transapical access and closure study), which was conducted at five European sites. Results indicated that Permaseal shortened operating time and hospital stay, reduced adverse events including the need for transfusion and reduced 12-month mortality and stroke rates to 0%. The press release adds that the technology provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including transcatheter aortic valve implantation (TAVI), transcatheter mitral valve implantation, and patent foramen ovale closure, and other minimally invasive cardiac procedures.
Michael Whitman, founder, president, and chief executive officer of Micro Interventional Devices, states: “Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures. We are excited that this technology is now available to our European surgeons and their patients. In the near future, PolyCor and MyoLast technologies will be used in a broad range of proprietary, catheter-based products, addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation.”