Rapid Medical’s Tigertriever 13 Evaluated in Interim Safety Analysis From DISTALS Study

September 4, 2024—Rapid Medical announced completion of the interim safety analysis of the DISTALS study at the European Society of Minimally Invasive Neurological Therapy’s ESMINT Congress 2024 held September 4-6 in Marseilles, France.

The multicenter, pivotal DISTALS study is enabled by the company’s Tigertriever 13 adjustable thrombectomy device. The study will examine the safety and effectiveness of mechanical thrombectomy using the Tigertriever 13 in distal stroke.

The company advised that, per protocol, the data safety and monitoring board (DSMB) analyzed all safety data—including the rate of symptomatic intracerebral hemorrhage—for 82 patients. The DSMB includes Josh Hirsch, MD; Thabele (Bay) Leslie-Mazwi, MD; Robert W. Regenhardt, MD; and Scott Hamilton, PhD. The data were adjudicated by the imaging core lab and the clinical event committee.

David Fiorella, MD, of Stony Brook University Medical Center in Stony Brook, New York, is the principal study investigator.

“We are pleased that the DSMB found that the safety profile of Tigertriever 13 allows us to continue randomization,” commented Dr. Fiorella in the company’s press release. “This reflects its unique design which facilitates thrombectomy procedures in smaller vessels given its low profile and adjustability.”

Walid Haddad, PhD, Chief Clinical Officer at Rapid Medical, added, “With safety at the core of the DISTALS study, the interim data is very reassuring. 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.”

In June 2022, the company announced the enrollment of the first patient in the study.