Surmodics Announces Early Results from PROWL Registry Study of Real-World Limb Ischemia Patients Treated with Pounce™ Thrombectomy System
Early subset analysis of 60 patients with acute, subacute, or chronic symptoms of limb ischemia demonstrated 96.8% procedural flow restoration, with 81.7% of subjects not receiving additional thromboemboli removal treatment post Pounce™ System use.
PROWL is an open-label, retrospective, multi-center,
The analysis examined subjects with symptomatic native, infrainguinal vessels, followed through 30 days. Procedural success, defined as restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (patient level success), was 90.0%. Nearly all (96.8%) of subjects experienced final post-procedural TIPI 2-3 blood flow restoration. Technical success, defined as restoration of blood flow to the target lesion(s) with <50% residual obstruction without the need to initiate catheter-directed therapies or to proceed to open surgery or other endovascular thrombectomy devices (lesion-level success), was 80.8%. Of the 60 subjects, 49 patients (81.7%) received no further thromboemboli removal treatment within 30 days post Pounce™ System use. Product use was well tolerated, with only 1 subject (1.7%) experiencing device-related adverse events.
Previous studies of aspiration thrombectomy for symptomatic limb ischemia excluded patients with symptom duration greater than 14 days1,2 or patients whose thrombi or emboli were not fresh.3 In the 60-patient PROWL cohort, 60.0% of patients presented with acute (≤14 days) limb ischemia, 16.7% with subacute (15-28 days) limb ischemia, and nearly 1 in 4 (23.3%) presented with chronic (>28 days) limb ischemia. Forty patients (66.7%) in the 60-patient cohort avoided an ICU admission, while 49 (81.7%) were discharged home.
“Although patients with limb ischemia often seek care acutely, many patients present after experiencing symptoms for several days or weeks,” said
“In terms of health care resource utilization, the high rate of ICU avoidance and discharge home in this very ill population is encouraging. We’re eagerly awaiting further results from this highly promising registry study,” he added.
About the Pounce Thrombectomy Platform
The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System,
Described as “grab-and-go” solutions, Pounce Thrombectomy Platform devices are both 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 Acute Limb Ischemia (ALI)
ALI is characterized by a sudden decrease in arterial perfusion to the limb, with a potential threat to limb survival, requiring urgent evaluation and management. Common causes include embolization due to cardiac dysrhythmia or thrombus from pre-existing peripheral artery disease.4 ALI is associated with 30-day amputation and mortality rates as high as 30% and 11.5%, respectively.5 ALI-related interventions may account for up to 16% of the case volume for vascular surgeons and be accompanied by hospitalization costs of
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Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including the statements regarding the potential number of patents and sites for the PROWL registry study, that the early PROWL results suggest that the Pounce Thrombectomy System may be effective as a standalone solution for removing acute-to-chronic clot in real-world clinical settings without adjunctive treatments, and regarding 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 outcome of the full PROWL registry study, 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
- Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584-592.
- de Donato G, Pasqui E, Sponza M, et al. Safety and efficacy of vacuum assisted thrombo-aspiration in patients with acute lower limb ischaemia: the INDIAN trial. Eur J Vasc Endovasc Surg. 2021;61(5):820-828.
- Lopez R, Yamashita TS, Neisen M, et al. Single-center experience with Indigo aspiration thrombectomy for acute lower limb ischemia. J Vasc Surg. 2020;72(1):226-232.
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Björck M, Earnshaw J, Acosta S, et al.
European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb Ischaemia. Eur J Vasc Endovasc Surg. 2020;59(2):173e218. - Gupta R, Siada SS, Bronsert M, Al-Musawi MH, Nehler MR, Jeniann AY. High Rates of Recurrent Revascularization in Acute Limb Ischemia–A National Surgical Quality Improvement Program Study. Ann Vasc Surg. 2022;87:334-342.
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