[junkie-button url=”https://infomeddnews.com/” style=”grey” size=”medium” type=”round” target=”_blank”] HOME [/junkie-button]
Aziyo reports patients undergoing femoral arterial reconstruction with patch angioplasty closure were eligible for the study, and a total of 43 patients were enrolled at three US centers. To date, there have been no device-related adverse events and no instances of patch infection. Primary patency as determined from duplex imaging was maintained in 97.6% of procedures at an average of seven months follow-up. Patients are being followed for 12 months post endarterectomy.
“This preliminary analysis of Aziyo’s biologic ECM for femoral arterial reconstruction demonstrates the product’s safety and efficacy in peripheral vascular reconstruction,” said Joshua D. Adams, M.D., principal investigator and vascular and endovascular surgeon at Carilion Clinic Vascular and Endovascular Surgery, and previously the Medical University of South Carolina. “Evidence also supports the antimicrobial properties of ECM, rendering it more resistant to infection than standard prosthetic material. Continued patient follow-up in the study will be important to further understand the long-term effectiveness of this unique biomaterial.”
“We sincerely appreciate the efforts of the surgeons and patients who are participating in the study,” commented Michelle LeRoux Williams, Ph.D., Chief Scientific Officer of Aziyo Biologics. “The preliminary data from PERFORM are encouraging. We believe this biologic ECM scaffold is an important solution for vascular repair as part of a surgeon’s regenerative medicine toolkit.”
PERFORM is a prospective, post-market, multi-center study evaluating the use of Aziyo’s biologic ECM scaffold in patients undergoing femoral arterial reconstruction. To be eligible for the study, patients must be indicated for femoral arterial reconstruction with patch angioplasty closure using ECM. Patient follow-up includes duplex imaging and assessment of adverse events through 4-6 weeks, 6 months and 12 months following endarterectomy.