PROWL REGISTRY: EARLY RESULTS

Real-world data on 74 infrainguinal, acute, subacute, and chronic limb ischemia patients1

Real-world data on 74 infrainguinal, acute, subacute, and chronic limb ischemia patients1

PROWL REGISTRY: EARLY RESULTS

What is the PROWL Registry?

Real-world study in adult patients presenting with symptoms of acute, subacute, or chronic limb ischemia in whom the Pounce™ Thrombectomy System was used for peripheral arterial thromboemboli extraction.

Procedural Success: Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (Patient-level success)

Technical Success: Restoration of blood flow to the target lesions(s) with <50% residual obstruction without the need to initiate CDT or to proceed to open surgery or other endovascular thrombectomy device (Lesion-level success)

Procedural Success: Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (Patient-level success)

Technical Success: Restoration of blood flow to the target lesions(s) with <50% residual obstruction without the need to initiate CDT or to proceed to open surgery or other endovascular thrombectomy device (Lesion-level success)

Study Design

Real-World Multicenter

Real-World Multicenter

Core-Lab Adjudicated

Core-Lab Adjudicated

Up to 30 Sites

Up to 30 Sites

≤ 500 Patients

30-days Post Procedure

≤ 500 Patients

30-days Post Procedure

Key Takeaways

The Pounce™ Thrombectomy Platform allowed for significant efficacy with high procedural success and 3 or fewer retrieval passes in most cases.

STAND-ALONE

STAND-ALONE

80%

No additional thrombus-removal treatment needed post-Pounce system use

―――――――― RAPID ――――――――

―――――――――― RAPID ――――――――――

20.3 min.

Average Pounce system use time

73%

Required 3 or fewer passes

RESTORE FLOW

RESTORE FLOW

97%

TIPI 2-3 (Final)

LOW COMPLICATIONS

81%

Discharged to home

LOW COMPLICATIONS

FAVORABLE ECONOMICS

68%

Avoided ICU admission

FAVORABLE ECONOMICS

Clot Type

Embolus
24.4%

Thrombus
73.0%

Unknown/Not Reported 2.7%

Clot Type

Embolus
24.4%

Thrombus
73.0%

Unknown/Not Reported 2.7%

Clinical Presentation

System Onset

Clinical
Presentation

Chronic Rutherford
Classification

Acute Rutherford
Classification

  • Key procedure adverse events
  • Transfusion (not device related): 1.4%
  • Device related flow limiting dissection: 1.4%
  • No device-related significant embolizationA
  • 30-day freedom from
  • All cause mortality: 94.6%B
  • Major amputation: 93.2%
  • CD-TLR: 91.9%

EFFICACY ENDPOINTS

  • Technical Success: 80.9% of target lesions
  • Restoration of blood flow to the target lesions(s) with <50% residual obstruction without the need to initiate Catheter-directed therapies (CDT) or to proceed to open surgery or other endovascular thrombectomy device.
  • Procedural Success: 90.5% of subjects
  • Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment
  • Complete or Substantial Thrombus Removal:
  • 93.5% (Core lab adjudicated) at end of procedure
  • 76.3% Following use of Pounce platform
  • Arterial flow (Core Lab): 97.1% TIPI Grade 2/3

SAFETY ENDPOINTS

  1. Requiring surgical procedure or obstructing one of the major downstream vessels >70% (at the end of the procedure)
  2. Reason for death: AKI (2), Sepsis (1), Shock (1); none device related

The Pounce™ Thrombectomy Platform

74 patients with symptomatic native, infrainguinal vessels have been treated with the Pounce system (3.5–6mm vessels) and Pounce™ LP (low profile) system (2–4mm vessels).

2–4mm vessel diameter

3.5–6mm vessel diameter

5.5–10mm vessel diameter

The Pounce™ Thrombectomy Platform is not available for sale outside the United States.

The data presented here does not currently include the Pounce™ XL Thrombectomy System.

1. Clair D. PROWL Registry: early results. Poster presented at: 37th annual International Symposium on Endovascular Therapy; February 2-5, 2025; Hollywood, FL.

Intended Use:

The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.

Contraindications:

The device is contraindicated for use in patients who cannot receive recommended intravenous anticoagulant therapy.