This section highlights FDA-related milestones and regulatory updates for drugs developed by Surmodics (SRDX).
Over the past two years, Surmodics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Pounce™ and SurVeil. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Pounce™ LP Thrombectomy System - FDA Regulatory Timeline and Events
Pounce™ LP Thrombectomy System is a drug developed by Surmodics for the following indication: Intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Pounce™ LP Thrombectomy System
- Announced Date:
- February 3, 2025
- Indication:
- Intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter.
Announcement
Surmodics, Inc. announced the successful early clinical use of its Pounce™ XL Thrombectomy System.
AI Summary
Surmodics, Inc. announced the successful early clinical use of its new Pounce™ XL Thrombectomy System. This device is designed to remove blood clots from peripheral arteries between 5.5 and 10 mm in diameter, which include the iliac and femoral arteries. During its first use, vascular surgeon Dr. Walter Rizzoni at the University of Pittsburgh Medical Center removed a significant amount of chronic clot from a thrombosed stent graft using the device. The Pounce XL system works by capturing and removing both acute and chronic clots without the need for aspiration, thrombolysis, or additional capital equipment. This innovative system expands Surmodics’ lineup and offers a standalone solution for rapid clot removal in the lower extremities, potentially reducing hospital stays and follow-up procedures while maintaining performance comparable to its other Pounce models.
Read Announcement- Drug:
- Pounce™ LP Thrombectomy System
- Announced Date:
- October 1, 2024
- Indication:
- Intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter.
Announcement
Surmodics, Inc. announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ XL Thrombectomy System
AI Summary
Surmodics, Inc. has recently received U.S. FDA 510(k) clearance for its Pounce™ XL Thrombectomy System. This new clearance means the device is now approved for the non-surgical removal of thrombi and emboli from peripheral arteries that measure between 5.5 and 10 mm in diameter, making it effective for treating arteries such as the iliac and femoral. The clearance expands the company’s mechanical thrombectomy solution portfolio, which already includes systems for smaller arteries, and aims to provide a rapid, efficient method to restore blood flow without relying on thrombolytic medications. Surmodics’ CEO highlighted this development as a major step towards a complete intervention solution that could also reduce the need for follow-up procedures. The company plans to launch a limited market release of the system in the first half of 2025, with wider commercialization to follow.
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SurVeil DCB - FDA Regulatory Timeline and Events
SurVeil DCB is a drug developed by Surmodics for the following indication: Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SurVeil DCB
- Announced Date:
- April 22, 2025
- Indication:
- Surmodics is a leading provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays
Announcement
Surmodics, Inc announced the publication of the TRANSCEND clinical trial, a global randomized study demonstrating the SurVeil™ drug-coated balloon (DCB) is non-inferior to the IN.
AI Summary
Surmodics, Inc. recently announced the publication of the TRANSCEND clinical trial, a global randomized study comparing the SurVeil™ drug-coated balloon (DCB) with the IN.PACT™ Admiral™ DCB in treating femoropopliteal arterial disease. The study demonstrated that the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB in terms of safety and effectiveness at 12 months. A key highlight of the trial is that the SurVeil DCB delivers treatment with a significantly lower dose of paclitaxel—2.0 μg/mm² compared to the 3.5 μg/mm² used by the IN.PACT Admiral, which is about 75% higher. These results offer strong evidence that a lower drug dose can maintain excellent therapeutic performance while ensuring patient safety, helping physicians make informed decisions in managing peripheral arterial disease.
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