12-Month Data from Surmodics’ TRANSCEND Trial Presented at LINC 2021 Event

Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 12-month data from its TRANSCEND clinical trial has been presented at the Leipzig Interventional Course (LINC) 2021 virtual event.

The TRANSCEND Trial is a global, multi-center, randomized, controlled clinical trial (RCT) with 1:1 randomization to the SurVeil DCB (Surmodics, Inc.) or IN.PACT Admiral DCB (Medtronic), in patients with symptomatic femoropopliteal artery disease. The primary efficacy endpoint was primary patency at 12 months, defined as a composite of freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis. The primary safety endpoint was a composite of freedom from device or procedure related death through 30 days and freedom from above-ankle amputation and clinically driven target vessel revascularization (CD-TVR) within 12 months.

Primary results, presented by TRANSCEND co-principal investigator Dr. Kenneth Rosenfield, M.D., demonstrate that the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB with regards to both safety and efficacy, while delivering a substantially lower drug dose.

“The TRANSCEND clinical trial is the first head-to-head pivotal RCT of a low-dose DCB (the SurVeil device) vs high-dose DCB (the IN.PACT Admiral device). The SurVeil DCB is a third-generation device that uses a substantially lower drug dose with an innovative drug-excipient formulation and process to achieve comparable clinical results. The drug coating is visibly different from other DCBs and is designed to improve drug consistency and uniformity while reducing particulate and downstream embolization, which are critical considerations in this patient population,” said Dr. Rosenfield. “I am very pleased with the results presented today and excited about the potential of the SurVeil DCB, which offers an attractive therapeutic alternative to improve the treatment of PAD.”

Both the SurVeil and IN.PACT Admiral DCBs utilize coatings with the anti-proliferative drug paclitaxel. However, the IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5 µg/mm2) than the SurVeil DCB, which has a 2.0 µg/mm² drug load.

In the TRANSCEND Trial, the SurVeil DCB was found to be non-inferior to the IN.PACT Admiral DCB in both the primary safety and primary efficacy endpoints. The SurVeil DCB cohort (N=222) exhibited a strong safety profile with 91.7% of subjects demonstrating freedom from device or procedure related death within 30 days and freedom from above-ankle amputation or CD-TVR within 12 months, compared to 89.6% of subjects treated with the IN.PACT Admiral DCB (N=224). The SurVeil DCB group, also met its efficacy endpoint of primary patency of 81.7% as compared to 85.9% of the IN.PACT Admiral DCB arm. In addition, the number of reinterventions deemed clinically necessary by physicians did not differ between the products.