Surmodics Announces Commercial Release of Pounce™ XL Thrombectomy System, Enabling Rapid Non-Surgical Clot Removal in Iliac and Femoral Arteries
With the addition of the Pounce™ XL Thrombectomy System, indicated for use in 5.5–10 mm peripheral arteries, the fully mechanical Pounce™ Thrombectomy Platform can now remove thrombi or emboli throughout the lower and upper extremities without aspiration, thrombolysis, or capital equipment
Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the commercial release of the Pounce™ XL Thrombectomy System, the latest in a suite of Pounce Thrombectomy systems that provide rapid endovascular removal of acute or chronic clot from peripheral arteries.
Intended for removal of thrombi and emboli from peripheral arteries ranging from 5.5–10 mm in diameter, sizes typical of iliac and femoral arteries, the Pounce XL Thrombectomy System complements the Pounce and Pounce LP (Low-Profile) Thrombectomy Systems, which are intended for use in 3.5–6 mm and 2–4 mm peripheral arteries, respectively. With a combined vessel diameter range of 2–10 mm, the Pounce Thrombectomy Platform provides a standalone solution for rapid removal of peripheral arterial thrombi and emboli throughout the lower and upper extremities.
Readily deployable and simple to use, the fully mechanical Pounce Thrombectomy Platform:
- Uses proprietary dual-basket technology to remove acute or chronic peripheral arterial clot without capital equipment
- Is associated with low risk of distal embolization1,2
- Does not require thrombolytics, optimizing single-session treatment
- Uses no aspiration for clot removal, minimizing blood loss
- Is atraumatic to vessel walls, with low risk of flow-limiting dissection1,3
The Pounce XL Thrombectomy System has been in limited market release (LMR) since January 2025. Dr. Anna Marjan, a vascular surgeon at Allina Health Mercy Hospital in Coon Rapids, Minnesota, was among the physicians who used the Pounce XL Thrombectomy System during the product's LMR.
"Removing organized clot from large peripheral arteries without a surgical cutdown can be very challenging," she said. "In our first use of the Pounce XL Thrombectomy System we were able to extract a large amount of acute and subacute clot from the infrarenal aorta and common iliac arteries in a severely ischemic patient with just 3 passes of the device. Avoiding surgical cutdown reduces the need for general anesthesia and reduces risk of surgical-site infection, which benefits patients. The Pounce Thrombectomy Platform is my first-line, go-to solution for endovascular thrombectomy in peripheral arteries."
The effectiveness and safety of the Pounce and Pounce LP Thrombectomy Systems are supported by real-world data from the PROWL registry, an open-label, retrospective, multicenter, U.S. study of the Pounce Thrombectomy Platform for the removal of emboli and thrombi in the peripheral arterial vasculature. In an interim analysis1 of 74 patients with acute, subacute, and chronic4 native infrainguinal vessel limb ischemia, average Pounce Thrombectomy Platform use time was 20.3 minutes, with 79.7% of patients receiving no additional clot removal treatment of the target lesion after Pounce Thrombectomy Platform use. Device-related adverse events were limited to one report of flow-limiting dissection.3
"The addition of the Pounce XL Thrombectomy System fulfills our vision of providing a simple, effective platform for removing peripheral arterial blood clots throughout the leg," said Gary Maharaj, President and Chief Executive Officer of Surmodics. "When minutes matter, physicians appreciate the availability of a readily deployable solution with a track record of dependable and safe results. We're proud of the growing clinical adoption of this product and the benefits it is bringing to limb ischemia patients in need of urgent care."
About the Pounce Thrombectomy Platform
The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System, Pounce LP (Low-Profile) Thrombectomy System, and the Pounce XL Thrombectomy System. All are FDA-cleared, fully mechanical thrombectomy systems intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. They are intended for use in peripheral arteries 3.5–6 mm, 2–4 mm, and 5.5–10 mm in diameter, respectively.
Described as "grab-and-go" solutions, Pounce Thrombectomy Platform systems are readily deployable and simple to use. The systems are composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.
About Surmodics, Inc.
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. Surmodics also develops and commercializes highly differentiated vascular intervention 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 modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Company's mission is 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 Securities and Exchange Commission.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements regarding our vision of providing a simple, effective platform for removing peripheral arterial blood clots throughout the leg, and Surmodics' 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 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, 2024, 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.
- Interim results from 74 patients with native infrainguinal vessel limb ischemia. Lyden S. Results of novel non-aspiration mechanical arterial thrombectomy device for acute and chronic lower extremity ischemia: PROWL registry study. 20th annual Leipzig Interventional Course (LINC); January 29, 2025; Leipzig, Germany.
- No device-related distal embolization requiring surgical procedure or obstructing one of the major downstream vessels >70% (at the end of the procedure) was reported in an interim analysis of 74 patients with native infrainguinal vessel limb ischemia in the PROWL registry.
- One device-related flow-limiting dissection was reported in an interim analysis of 74 patients with native infrainguinal vessel limb ischemia in the PROWL registry. No device-related distal embolization, perforations, or major bleeding (requiring transfusion) were reported.
- Acute, subacute, and chronic limb ischemia were defined as time from symptom onset of ≤14 days, 15–28 days, and >28 days, respectively.
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