This Surmodics marketing image shows three SurVeil drug-coated balloons for treating PAD.
SurVeil drug-coated balloons [Image courtesy of Surmodics]

Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies.

The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York.

In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact Admiral DCB. The trial evaluated the devices in the treatment of proximal popliteal artery lesions. Data came from 36 months of evaluation with 446 patients participating.

SurVeil received a long-awaited FDA approval in June of this year.

Surmodics’ SWING first-in-human study evaluated the safety and performance of the Sundance sirolimus DCB. The 35-subject study evaluated the DCB in the treatment of occlusive disease of the infrapopliteal arteries. Data came from 24 months of evaluation.

Sundance won FDA breakthrough device designation more than four years ago.

Surmodics shares positive SurVeil data

The TRANSCEND trial randomized patients to the low-dose paclitaxel SurVeil balloon or the high-dose In.Pact Admiral DCB. It took place across 65 sites in the U.S., Australia, Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New Zealand.

Surmodics said the primary efficacy endpoint was 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization (CD-TLR). That proved comparable between the two balloons (82.2% vs. 85.9%).

The trial defined the primary safety endpoint as freedom from device- or procedure-related death within 30 days and above-ankle amputation or CD-TVR within 12 months. That also proved comparable between SurVeil (91.8%) and In.Pact Admiral (89.9%).

Surmodics said data demonstrated noninferiority for SurVeil in comparison to In.Pact Admiral with respect to both safety and efficacy. The trial proved this while SurVeil delivered a substantially lower drug dose. In.Pact Admiral has a 75% higher drug load of paclitaxel, the company said.

“The TRANSCEND 36-month data continues to demonstrate safe and effective performance of the SurVeil DCB. SurVeil DCB is a best-in-class, high-quality treatment option for our PAD patients utilizing a next-generation surface coating with a lower dose of Paclitaxel compared to IN.PACT Admiral DCB,” said Dr. Peter A. Schneider.

Good news on Sundance, too

SWING enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries. This population included a reference vessel diameter of 2 mm to 4 mm, and a total lesion length of ≤230 mm. Subjects received Sundance DCB treatment at eight sites in Australia, New Zealand and Europe.

Investigators defined the primary safety endpoint as the number of subjects with a composite of freedom from major adverse limb event (MALE) and perioperative death at 30 days following the index procedure. The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography. Surmodics reported that the trial achieved both primary endpoints of the SWING Trial.

The trial reported no perioperative deaths or major amputations at 30 days. It reported just one major intervention among the 35 subjects. The per-protocol population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularization) at six months. Surmodics saw no additional adverse events in that population in the 12- or 24-month data.

Primary efficacy data demonstrated a late lumen loss of 1 mm across 35 lesions at six months. That indicates sustained large luminal gain post-procedure. Surmodics reported 71.4% target lesion primary patency rate in the per-protocol population.

“The two-year safety and performance results of the SWING trial continue to show promise for the Sundance sirolimus DCB in treating below-the-knee disease in a challenging [chronic limb-threatening ischemia] patient population where options are currently limited,” said Professor Andrew Holden, director of Northern Region Interventional Radiology Service (Auckland City Hospital, Auckland, New Zealand), and co-lead investigator.