Micro Interventional Devices said today it won FDA 510(k) clearance for its Permaseal transapical access and closure device.
The Permaseal device is designed to allow surgeons to access and close the left-ventricle without having to suture the myocardium using the companies compliant soft-tissue PolyCor anchor technology.
“The FDA market clearance of Permaseal is another tremendous achievement for MID. This exciting development comes fast on the heels of our recent European approval. Sales in Europe are exceeding our early expectations. With the US approval, coming earlier than expected, MID will be initiating its US commercialization ahead of schedule. As I recently commented, 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 US and European surgeons and their patients. In the near future, PolyCor and MyoLastTM technologies will be utilized in a broad range of proprietary, catheter-based products addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation. MID’s technology platform enables open-surgical procedures to be performed percutaneously,” CEO Michael Whitman said in a prepared statement.
MID touted data from a clinical study of the device conducted at 5 European sites which indicated a reduction in operation time, hospital stays and adverse events with use of the device, as well as lowered 12-month mortality and a 0% rate of stroke.
The company won CE Mark approval in the European Union 7 weeks prior to its FDA win.