Advertisement
Advertisement
October 14, 2024
Penumbra’s THUNDER IDE Study Completes Enrollment
October 14, 2024—Penumbra, Inc. announced the completion of enrollment in its THUNDER clinical study for patients with acute ischemic stroke. THUNDER is evaluating the safety and efficacy of the company’s latest computer-assisted vacuum thrombectomy (CAVT) technology, the Penumbra system with Thunderbolt aspiration tubing, for the removal of blood clots in the brain. The study is being conducted under an investigational device exemption granted by the FDA.
According to the company, THUNDER is a multicenter, single-arm study evaluating patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy. The primary efficacy endpoint includes revascularization of the occluded target vessel at immediate postprocedure.
In the press release, the company stated that the Penumbra system with Thunderbolt aspiration tubing uses an advanced CAVT software algorithm to generate modulated aspiration, reducing friction between the clot and reperfusion catheter and facilitating a more rapid and complete removal of blood clots in the brain. Thunderbolt aspiration tubing has been designed for use with Penumbra Engine and Red reperfusion catheters, noted the company.
Advertisement
Advertisement
