Aziyo Touts Positive Initial Data from Clinical Study of Biologic Extracellular Matrix Scaffold for Femoral Arterial Reconstruction.
M2 PHARMA-November 17, 2017-Aziyo Touts Positive Initial Data from Clinical Study of Biologic Extracellular Matrix Scaffold for Femoral Arterial Reconstruction
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- US-based regenerative medicine company Aziyo Biologics, Inc is touting positive results from PERFORM, a prospective, post-market study conducted in patients undergoing femoral arterial reconstruction using the company's biologic extracellular matrix (ECM) scaffold., the company said.
There were no device-related adverse events or infections and primary patency was maintained in 97.6% of procedures.
The preliminary results were presented at the VEITHsymposium 2017 by Joshua D. Adams, M.D.
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.
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.
Aziyo's biologic extracellular matrix for vascular repair is constructed from a multi-laminate sheet of decellularized, non-crosslinked, lyophilized extracellular matrix derived from porcine small intestinal submucosa.
Once implanted, evidence shows that over time the ECM transforms into vascularised tissue. The Extracellular Matrix for Vascular Repair has been implanted in more than 30,000 procedures.
The Extracellular Matrix for Vascular Repair is a 510(k) FDA cleared medical device, intended for use as a patch material for the repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral and tibial blood vessels.
Porcine SIS is a decellularized matrix that serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures.
The ECM is gradually replaced as the patient's own cells restore the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. Since 1999, an estimated two m patients worldwide have received SIS ECM implants.
Aziyo Biologics was formed by HighCape Partners, Deerfield Management Co. and KeraLink International.
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|Date:||Nov 17, 2017|
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