Results from a prospective, nonrandomized, multicenter, first-in-human study of 19 patients with acute vein thrombosis followed to 12 months.1
CLINICAL DATA
12-MONTH DATA
Clinical Study Objective
Demonstrate the performance of the Pounce™ Venous Thrombectomy System in patients with acute vein thrombus.
Procedural Success: The primary performance end point for the study was defined as procedural success through the preparation and use of the device to achieve Society of Interventional Radiology (SIR) grade II lysis (50%-95% thrombus removal) or above, with freedom from procedural adverse events.
Study Design
Prospective
Multi-site
Non-randomized
Core-lab Adjudicated
Key Takeaways
EFFICACY
100%
Procedural
success in
single-session2
SPEED
3 passes
or fewer to
achieve
endpoint3
23 minutes
Median thrombectomy time4
SAFETY
0%
SAEs or
device-related
complications
PTS (12 MONTH)
0%
Freedom from
moderate to
severe PTS5
- Black SA, Thulasidasan N, Benton L, et al. Single-session mechanical thrombectomy for iliofemoral deep vein thrombosis using a dual mechanism of action device combining basket and rotational thrombectomy. J Vasc Surg Venous Lymphat Disord. 2024;12(5):101866.
- Based on primary end point clot removal success being SIR Grade II Lysis or better.
- Device pass defined as the action of withdrawing the device through the treatment site.
- Thrombectomy time defined as introduction of Pounce Venous Thrombectomy System to final device removal (includes imaging assessments between passes where applicable).
- Post-thrombotic syndrome (PTS) at 12-month follow up (N=11) defined as clinically significant PTS scored via Villalta score as being severe (>=15) or moderate (10-14).
EFFICACY
100%
Procedural success in single-session2
Key Takeaways
SPEED
3 passes
or fewer to achieve
endpoint3
23 minutes
Median thrombectomy time4
SAFETY
0%
SAEs or device-related complications
PTS (12 MONTH)
0%
Freedom from moderate to severe PTS5
- Black SA, Thulasidasan N, Benton L, et al. Single-session mechanical thrombectomy for iliofemoral deep vein thrombosis using a dual mechanism of action device combining basket and rotational thrombectomy. J Vasc Surg Venous Lymphat Disord. 2024;12(5):101866.
- Based on primary end point clot removal success being SIR Grade II Lysis or better.
- Device pass defined as the action of withdrawing the device through the treatment site.
- Thrombectomy time defined as introduction of Pounce Venous Thrombectomy System to final device removal (includes imaging assessments between passes where applicable).
- Post-thrombotic syndrome (PTS) at 12-month follow up (N=11) defined as clinically significant PTS scored via Villalta score as being severe (>=15) or moderate (10-14).
“I found the [Pounce™ Venous System] very effective at removing clot and very straightforward to use… outcomes show a great deal of promise in improving outcomes in the management of clot in the peripheral vasculature.“
Physician Experience
“Really very exciting. Very straightforward to use.”
Professor Stephen Black
Guy’s and St. Thomas’ NHS Foundation Trust, London
Disclosures: Dr. Stephen Black is a consultant for Surmodics.
PRIMARY ENDPOINTS
- Successful clot removal procedure6
- Freedom from procedural AEs
SECONDARY ENDPOINTS
- Venous disease severity
- Villalta score
- VCSS
- Quality of life
- VEINS QoL
- Calf circumference
- Successful clot removal procedure defined by achievement of SIR Grade II Lysis or better.
More information about the Pounce™ Venous Thrombectomy System
Intended Use:
The device is indicated for mechanical de-clotting and controlled, and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
Contraindications:
- Patients contraindicated for endovascular procedures
- Patients who cannot tolerate contrast media
- Patients in whom the lesion cannot be accessed with the guide wire
- Veins less than 6 mm diameter