Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that 36-month data from its TRANSCEND clinical trial will be presented at the upcoming 50th Annual VEITH Symposium in New York, New York.
Dr. Peter A. Schneider, Professor of Surgery at University of California, San Francisco and Member of the TRANSCEND Trial Steering Committee, will present the TRANSCEND trial’s safety and efficacy data through 36 months as part of a November 15, 2023 session focused on randomized controlled trial (RCT) updates on new developments in drug coated balloons (DCBs) and drug eluting stents (DESs).
Preliminary schedule details are provided below.
TITLE:
3-Year Results of A RCT Comparing SurVeil DCBs (Surmodics) With In.Pact DCBs (Medtronic) For Treating FemPop Lesions: From the TRANSCEND Trial
SPEAKER: Dr. Peter A. Schneider
DATE/TIME: Wednesday, November 15, 2023
SESSION 26: New Developments in Drug Coated Balloons (DCBs) and Drug Eluting Stents (DESs): Updates on Randomized Controlled Trials (RCTs) and BTK Lesion Treatments with DCBs And DESs
Presentation: 10:30 a.m. to 10:35 a.m. (EST)
About the TRANSCEND Clinical Trial
The TRANSCEND trial randomized 446 patients at 65 global sites to assess the safety and efficacy of the SurVeil™ drug coated balloon (DCB) versus the IN.PACT® Admiral® DCB for treatment of superficial femoral and proximal popliteal artery lesions. The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization (CD-TLR). 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. Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025. Additional acute and long-term secondary endpoint data is being assessed through 5 years of follow-up.
The 12-Month and 24-Month data were presented by Dr. Kenneth Rosenfield at the Leipzig Interventional Course (LINC) in 2021 and at Vascular InterVentional Advances (VIVA) 2022 respectively. 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 (3.5 μg/mm2) than the SurVeil DCB, which has a 2.0 μg/mm² drug load.
About the SurVeil DCB
The SurVeil DCB, a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease (PAD), 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 FDA approval in the United States in June 2023.
In February 2018, Surmodics entered into an agreement with Abbott (NYSE: ABT) that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB. With U.S. regulatory approval of the device, Surmodics will retain 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 sales to third parties.