Surmodics announces 36-month data from TRANSCEND trial

Surmodics announced that 36-month data from its TRANSCEND clinical trial was presented by Peter Schneider at the 50th Annual VEITH Symposium in New York, New York. The TRANSCEND trial is a prospective, multi-center, single-blind, randomized, controlled trial to assess the safety and efficacy of the SurVeil drug coated balloon versus the IN.PACT Admiral DCB for treatment of superficial femoral and proximal popliteal artery lesions. A total of 446 patients were randomized to either the low-dose paclitaxel SurVeil DCB or the high-dose paclitaxel IN.PACT Admiral DCB at 65 sites in the United States, Australia, Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New Zealand. The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization. Primary patency was comparable between the SurVeil DCB and IN.PACT Admiral. The primary safety endpoint is freedom from device or procedure related death within 30 days and above-ankle amputation or CD-TVR within 12 months, which also demonstrated comparable outcomes between SurVeil DCB and IN.PACT Admiral DCB. Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025. Data demonstrates 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. 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 than the SurVeil DCB, which has a 2.0 undefined/mm drug load. Patient outcomes are being collected at 1, 6, 12, 24, 36, 48, and 60 months. Intermediate-term secondary outcomes included clinically driven target lesion revascularization, major target limb amputation (TLA), thrombosis at the target lesion, and historical major adverse events. A total of 352/363 patients completed their 36-month visit. The SurVeil DCB, which previously demonstrated noninferior primary safety and effectiveness outcomes through 12 months with a lower paclitaxel dose, continues to demonstrate similar outcomes at intermediate-term follow-up of 36 months compared with the high-dose IN.PACT Admiral DCB in the treatment of patients with symptomatic peripheral artery disease, or PAD, caused by stenosis of the femoral and/or popliteal arteries. Results at 36 months for SurVeil versus IN.PACT Admiral were statistically comparable, including CD-TLR, major TLA, thrombosis at the target lesion and historical MAEs.