Surmodics Releases 36-Month TRANSCEND Trial Data

Thirty-six month data from Surmodics Inc.’s TRANSCEND clinical trial show the company’s SurVeil drug-coated balloon (DCB) is basically equivalent to the IN.PACT Admiral DCB.  
 
The TRANSCEND trial is a prospective, multi-center, single-blind, randomized, controlled study to assess SurVeil’s safety and efficacy compared with IN.PACT Admiral for treating superficial femoral and proximal popliteal artery lesions. Four hundred forty-six patients were randomized to either the low-dose paclitaxel (2 µg/mm2) SurVeil DCB (n = 222) or the high-dose (3.5 µg/mm2) paclitaxel IN.PACT Admiral DCB (n = 224) 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 (CD-TLR). Primary patency was comparable between the SurVeil DCB and IN.PACT Admiral (82.2% vs 85.9%). 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 (91.8% vs 89.9%). 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 regarding safety and efficacy, but delivers a substantially lower drug dose. Both the SurVeil and IN.PACT Admiral DCBs use paclitaxel coatings. 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 μg/mm2 drug load.
 
Patient outcomes are being collected at one, six, 12, 24, 36, 48, and 60 months. Intermediate-term (36-month) secondary outcomes included CD-TLR, major target limb amputation (TLA), thrombosis at the target lesion, and historical major adverse events.
 
Three hundred fifty-two of 363 (96.97%) 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 36 month follow-up compared with the high-dose IN.PACT Admiral DCB in treating symptomatic peripheral artery disease (PAD) caused by femoral and/or popliteal arterial stenosis. Results at 36 months for SurVeil versus IN.PACT Admiral were statistically comparable, including CD-TLR (20.3% vs 19.5%; P =0.897), major TLA (0.0% vs 0.5%; P = 1.000), target lesion thrombosis (0.6% vs 0.0%; P = .475), and historical major adverse events (28.6% vs 28.5%; P = 1.000).
 
“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 Peter A. Schneider. M.D., a vascular surgeon in San Francisco. 
 
The SurVeil DCB is a next-generation device that utilizes best-in-class technology to treat peripheral artery disease. It includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. The SurVeil DCB received CE Mark Certification in the European Union in June 2020 and received U.S. Food and Drug Administration approval in June 2023.
 
In February 2018, Surmodics entered into an agreement with Abbott that provided the latter firm with exclusive worldwide commercialization rights for the SurVeil DCB. With U.S. regulatory approval of the device, Surmodics retains responsibility for manufacturing commercial quantities of the product and will realize revenue from product sales to Abbott as well as a share of profits resulting from third-party sales.
 
Surmodics is a global developer of surface modification technologies for intravascular medical devices and a provider of chemical components for in-vitro diagnostic (IVD) immunoassay tests and microarrays. Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the company’s expertise in proprietary surface technologies, along with enhanced device design, development, and manufacturing capabilities. Surmodics is headquartered in Eden Prairie, Minn.