Sunday, December 4, 2011

Company Receives FDA Clearance

Aptus Endosystems, Inc, the developer of an advanced technology for Endovascular Aneurysm Repair (EVAR), has received 510(k) clearance for the Aptus EndoStapling System known as the HeliFX™ Aortic Securement System. The system enables independent endograft fixation and is designed to mimic the hand suturing performed during open surgical repair of Abdominal Aotic Aneurysms (AAA).

Each year, an estimated 200,000 people in the U.S. and 100,000 people in Europe are diagnosed with AAA. EVAR is an alternative to open surgical repair of AAA, when a minimally invasive catheter-based system is used to implant a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death.

The system provides physicians with a novel technology to repair endovascular grafts that have migrated away from the implant site, have developed endoleaks, or are at risk of developing these complications which are commonly seen after EVAR. In such cases, augmented fixation and/or sealing is required to regain or maintain effective aneurysm exclusion. The system can also be used during initial EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms.

To make the decision, FDA reviewed the data available from 154 patients who were implanted with 810 EndoStaples and were monitored with routine follow-up CT scans. After a year, none of the EndoStaples had fractured and none of the patients experienced endograft movement, but one patient did need an additional intervention to address an endoleak.

“The FDA clearance of the system is a major milestone for Aptus and a significant technological advancement in the field of EVAR,” said Jeff Elkins, CEO for Aptus Endosystems. “The intuitive physician-directed implant technique and HeliFX’s ability to be used with market-leading endografts have the potential to clinically benefit a large number of patients who otherwise have few proven treatment alternatives.”