Penumbra (NYSE:PEN) said a 198-patient trial of its next-generation stroke-treatment device along with another company product showed promise, meeting primary endpoints. Results were positive enough that a 2016 regulatory submission remains part of the plan.
“The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to pursue regulatory submission by the end of the year,” Penumbra Chairman and CEO Adam Elsesser said in prepared remarks.
“Furthermore,” Elsesser added, “the broader implications of the data support frontline use of the Penumbra system direct aspiration devices in the vascularization of stroke patients.”
The Alameda, Calif.-based company presented details on July 27 as part of the Society of NeuroInterventional Surgery 13th Annual Meeting in Boston, Mass.
Researchers said that Penumbra’s 3D Revascularization Device, when used with the company’s Penumbra System aspiration devices, showed non-inferiority in both safety and efficacy, versus use of the Penumbra System aspiration devices on their own.
The revascularization rate in the Penumbra 3D plus aspiration device arm, hit 83.8%. For the aspiration device-only arm, the number was much lower, at 74.1%. Researchers noted that this compared favorably to the 71 percent revascularization rate published in the HERMES meta-analysis of five major randomized controlled trials in acute ischemic stroke.
Penumbra’s trial took place at 25 U.S. centers. Penumbra 3D is designed to be used with the company’s reperfusion catheters. Combined, they’re designed to remove stroke-causing vessel blockages both safely and effectively.
Also in July, Penumbra disclosed the U.S. launch of its Ace68 Reperfusion thrombectomy catheter, a device that extracts a blood clot that impedes blood flow in acute ischemic stroke patients.