Rapid Medical™: Interim Safety Analysis of DISTALS Study with TIGERTRIEVER™13 Shows No Safety Concerns for Medium Vessel Occlusions

YOKNEAM, Israel & SOUTHLAKE, Texas & MARSEILLE, France--Rapid Medical™, a prominent developer of advanced endovascular devices, announced the successful completion of the interim safety analysis of the DISTALS Study during 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," commented Dr. David Fiorella of Stony Brook University Medical Center in Stony Brook, NY, and Principal Study Investigator.

In accordance with the study 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). The board consists of 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).

The TIGERTRIEVER™ 13's adjustability allows it to engage the clot and then relax, minimizing vessel traction during removal. Published data suggest that distal stroke treatment with TIGERTRIEVER 13 can result in higher revascularization success and improved post-treatment patient outcomes. Specifically, it demonstrated a 78% success rate in recanalization compared to 42% with Medical Management.

"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."

Rapid Medical is known for advancing neurovascular treatment through its development of pioneering interventional devices aimed at treating both ischemic and hemorrhagic stroke. The company's products are notable for being remotely adjustable and fully visible, thanks to proprietary manufacturing techniques. This adjustability allows physicians to tailor their approach in real-time, enhancing procedural outcomes for patients.

TIGERTRIEVER™ 13, 17 and 21, COMANECI™, and COLUMBUS™/DRIVEWIRE are all CE marked and FDA cleared, while TIGERTRIEVER XL also holds CE marking. These devices embody Rapid Medical's commitment to improving neurovascular treatment by providing innovative solutions that meet the diverse needs of patients and healthcare providers alike.

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