EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--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 will be presented at the upcoming Leipzig Interventional Course (LINC) 2021 virtual event. Dr. Kenneth Rosenfield, a principal investigator of the TRANSCEND study, will present as part of a January 25 late-breaking trial session on new data and innovative concepts for treatment of femoral arteries. Preliminary schedule details are provided below:
TITLE: |
Results of the TRANSCEND study – the randomized and controlled noninferiority trial to evaluate safety and clinical efficacy of the SurVeil™ drug-coated balloon compared to IN.PACT® Admiral® drug-coated balloon in the treatment of femoropopliteal artery disease. |
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SPEAKER: |
Dr. Kenneth Rosenfield |
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SESSION: |
LATE BREAKING TRIAL SESSION: New data and innovative concepts for treatment of femoral arteries – part I |
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DATE/TIME: |
January 25, 2021 |
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Session - 6:15 a.m. to 7:10 a.m. (CST) |
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TRANSCEND trial presentation - 6:45 a.m. to 6:50 a.m. (CST) |
About the TRANSCEND Clinical Trial
The TRANSCEND randomized trial enrolled 446 patients at 65 global sites to assess the safety and effectiveness 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 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-TLR within 12 months. Non-inferiority is tested using a multiple imputation approach at one-sided alpha 0.025.
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.
About Surmodics, Inc.
Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading 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. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that the company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about the anticipated presentation on the TRANSCEND clinical trial, the potential clinical uses of the SurVeil DCB, and the company’s growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including changes to the schedule of the LINC 2021 virtual event and the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2020, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at https://surmodics.gcs-web.com and at the SEC website at www.sec.gov. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
