Penumbra has announced the completion of enrolment in its THUNDER investigational device exemption (IDE) clinical study for patients with acute ischaemic 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. This multicentre, single-arm study is evaluating patients with acute ischaemic stroke secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy, and its primary efficacy endpoint includes revascularisation of the occluded target vessel immediately post-procedure.
“This critical milestone brings us another step closer to providing physicians with the latest technology for stroke management,” said Adam Elsesser, president and chief executive officer of Penumbra. “The THUNDER study will provide the dataset needed to evaluate Penumbra’s Thunderbolt technology and I am optimistic that we are at the dawn of a new era in stroke treatment.”
As stated in a press release, the Penumbra system with Thunderbolt aspiration tubing uses an advanced CAVT software algorithm to generate proprietary, 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 the Penumbra Engine and Red reperfusion catheters, the release adds.
