TRANSCEND Trial Evaluates Surmodics’ SurVeil Paclitaxel-Coated Balloon at 12 Months

January 25, 2021—Surmodics, Inc. announced 12-month data from the TRANSCEND randomized controlled trial (RCT), which is evaluating the company’s SurVeil drug-coated balloon (DCB) in patients with symptomatic femoropopliteal artery disease.

The global, multicenter TRANSCEND randomized patients 1:1 to receive either the SurVeil DCB or the In.Pact Admiral DCB (Medtronic). Surmodics announced the commencement of enrollment for the pivotal TRANSCEND RCT in November 2017.

The primary results demonstrated that the SurVeil DCB is noninferior to the In.Pact Admiral DCB with regards to both safety and efficacy, while delivering a substantially lower drug dose. Both devices utilize paclitaxel coatings, but the In.Pact Admiral DCB has a 75% higher drug load of paclitaxel than the SurVeil DCB (3.5 µg/mm² vs 2.0 µg/mm²), noted the company.

TRANSCEND coprincipal investigator Kenneth Rosenfield, MD, presented the findings at LINC 2021, the Leipzig Interventional Course being held as a virtual event January 25-29.

According to Surmodics, the trial’s 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.

The company stated that the SurVeil DCB cohort (n = 222) exhibited a strong safety profile with 91.7% of patients demonstrating freedom from device- or procedure-related death within 30 days and freedom from above-ankle amputation or CD-TVR within 12 months versus 89.6% of patients in the In.Pact Admiral DCB cohort (n = 224). Additionally, the SurVeil DCB group met its efficacy endpoint of primary patency of 81.7% as compared to 85.9% of the In.Pact Admiral DCB arm. The number of reinterventions deemed clinically necessary by physicians did not differ between the products.

“The TRANSCEND clinical trial is the first head-to-head pivotal RCT of a low-dose DCB—the SurVeil device—versus high-dose DCB—the In.Pact Admiral device,” commented Dr. Rosenfield in the company’s announcement. “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.

“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.”

The SurVeil DCB received European CE Mark approval in June 2020. In the United States, the device is not available for sale and is for investigational use only. In February 2018, Surmodics announced an agreement that granted Abbott exclusive worldwide commercialization rights for the SurVeil DCB.