Rapid Medical™ Reports No Safety Concerns for Medium Vessel Occlusions in the Interim Safety Analysis of the DISTALS Study with TIGERTRIEVER™13
The multi-center, pivotal DISTALS Study is enabled by TIGERTRIEVER 13, the smallest thrombectomy device for ischemic stroke.
YOKNEAM, Israel & SOUTHLAKE, Texas & MARSEILLE, France–(BUSINESS WIRE)– Rapid Medical™, a leading developer of advanced endovascular devices, announces completion of the interim safety analysis of the DISTALS Study at the 2024 Congress of the European Society of Minimally Invasive Neurological Therapy (ESMINT) Congress.
“We are pleased that the DSMB found that the safety profile of TIGERTRIEVER 13 allows us to continue randomization. This reflects its unique design which facilitates thrombectomy procedures in smaller vessels given its low profile and adjustability,” comments Dr. David Fiorella of Stony Brook University Medical Center in Stony Brook, NY, and Principal Study Investigator.
Per protocol, all safety data, including the rate of symptomatic intracerebral hemorrhage (sICH), was analyzed for 82 patients by the Data Safety and Monitoring Board (DSMB), which includes Drs. Josh Hirsch, MD, Thabele (Bay) Leslie-Mazwi MD, Robert W. Regenhardt MD, PhD, and Scott Hamilton, PhD. The data was adjudicated by the imaging core lab and the Clinical Event Committee (CEC).
TIGERTRIEVER™ 13’s adjustability engages the clot and then relaxes to minimize vessel traction upon removal. Published data indicates distal stroke treatment performed with TIGERTRIEVER 13 can lead to higher revascularization success and post-treatment patient outcomes, with 78% recanalization success vs. 42% with Medical Management.1,2,3,4 “With safety at the core of the DISTALS Study, the interim data is very reassuring,” said Dr. Walid Haddad, Chief Clinical Officer at Rapid Medical. “We are thrilled to partner with a rigorous team of physicians to expand thrombectomy to under-treated areas of the brain like medium vessel stroke.”
About Rapid Medical
Rapid Medical expands what’s possible in neurovascular treatment by pioneering advanced interventional devices that treat ischemic and hemorrhagic stroke. Utilizing proprietary manufacturing techniques, Rapid Medical’s products are remotely adjustable and fully visible. This enables physicians to respond in real-time to the anatomy and tailor the approach to every patient for better procedural outcomes. TIGERTRIEVER™ 13, 17 and 21, COMANECI™ and COLUMBUS™/DRIVEWIRE are CE marked and FDA cleared. TIGERTRIEVER XL is also CE marked. More information is available at www.rapid-medical.com
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REFERENCES:
- Ospel JM, Menon BK, Demchuk AM, et al. Clinical Course of Acute Ischemic Stroke Due to Medium Vessel Occlusion With and Without Intravenous Alteplase Treatment. Stroke. 2020;51(11):3232-3240. doi:10.1161/STROKEAHA.120.030227
- Rikhtegar R, Mosimann PJ, Weber R, et al. Effectiveness of very low profile thrombectomy device in primary distal medium vessel occlusion, as rescue therapy after incomplete proximal recanalization or following iatrogenic thromboembolic events. J Neurointerv Surg. 2021;13(12):1067-1072. doi:10.1136/neurintsurg-2020-017035
- Fischer S, Will L, Phung T, Weber W, Maus V, Nordmeyer H. The Tigertriever 13 for mechanical thrombectomy in distal and medium intracranial vessel occlusions. Neuroradiology. 2022;64(4):775-783. doi:10.1007/s00234-021-02792-x
- Guenego A, Mine B, Bonnet T, et al. Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13) [published online ahead of print, 2021 Sep 13]. Interv Neuroradiol. 2021;15910199211039926. doi:10.1177/15910199211039926
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Contacts
Ronen Eckhouse
+972-72-2503331
ronen@rapid-medical.com