EDEN PRAIRIE, Minn.– Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 6-month data from its SWING first-in-human (FIH) study of the company’s Sundance™ Sirolimus drug-coated balloon (DCB) was shared at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
The SWING study is a prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infra-popliteal arteries.
The study’s primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects. Data for the primary efficacy endpoint show a Late Lumen Loss (LLL) of 1.0 mm (± 0.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained six months post-treatment.
“At 6 months we observed a consistent improvement in Rutherford category and functional measures, as well as an excellent primary patency of 88.5%, which compares favorably to other drug coated balloons used in the infrapopliteal circulation,” said SWING trial co-lead investigator Professor Ramon Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi).
The Swing Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter (RVD) of 2 mm to 4 mm, and a total lesion length of ≤230 mm for treatment with the Sundance Sirolimus DCB at eight sites in Australia, New Zealand, and multiple locations in Europe. They will be followed for 36 months following the index procedure.
“The novel coating on the Sundance Sirolimus DCB was evaluated in a challenging, predominantly CLI population with a high proportion of diabetes and moderate-severe calcification,” said trial co-lead investigator Professor Andrew Holden, MD, MBChB, FRANZCR, EBIR, ONZM. “This first-in-human study demonstrates that the Sundance Sirolimus DCB could be a safe and promising treatment for occlusive disease of the infrapopliteal arteries.”
