Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon
The SurVeil DCB may now be marketed and sold in the
“Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said
Abbott has exclusive worldwide commercialization rights for the SurVeil DCB.
“I am excited that the Surveil DCB will be available to treat patients in the US,” said
SurVeil DCB TRANSCEND Trial Results Summary
24-month clinical trial results demonstrated the sustained durability of SurVeil DCB safety and efficacy outcomes.1 SurVeil DCB remained non-inferior to market-leading IN.PACT® Admiral® DCB at a substantially lower drug dose. At 24 months:
- 81.8% of subjects treated with the SurVeil DCB met the secondary safety endpoint, a composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically driven target vessel revascularization (CD-TVR) vs. 83.2% of subjects treated with the IN.PACT Admiral DCB.
- Less than 15% of patients in both arms of the trial required repeat revascularization procedures. One patient in the IN.PACT group required major leg amputation.
- Primary patency rate for SurVeil DCB subjects was 70.8% vs. 70.4% for IN.PACT Admiral.
Both the SurVeil and IN.PACT Admiral DCBs utilize paclitaxel drug 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 2.0 µg/mm² drug load. The design of the SurVeil DCB is intended to provide more uniform drug distribution, better efficiency of drug transfer, and fewer downstream particulates and downstream emboli.
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.
About
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about Surmodics’ manufacture and supply of SurVeil DCB products and the potential product revenue the company may realize, the milestone payment the company expects to receive from Abbott and the amount and timing of revenue recognition related to the milestone payment, 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 the actions of Abbott, the availability of components to manufacture SurVeil DCB products, the stability of SurVeil DCB manufacturing and sterilization processes at commercial scale, future accounting estimates related to the recognition of revenue from milestone payments, 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
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Rosenfield K. Intermediate-Term (24-Month) Results of the TRANSCEND Study Comparing a Next-Generation Paclitaxel Drug-Coated Balloon (SurVeil DCB) to IN.PACT DCB in the Treatment of Femoropopliteal Artery Disease. Presented at the 20th Annual VIVA (Vascular InterVentional Advances) conference;
November 1, 2022 ;Las Vegas, Nevada .
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