German device maker Phenox today released data from a study of its pREset thrombectomy device, touting high rates of positive clinical outcomes and freedom from severe neurological deficits.
The 100-patient trial examined a total of 109 acute intracranial vessel occlusions treated with the pREset device, looking to evaluate the efficacy of the device, overall safety and long-term outcomes. The trial included patients with acute proximal occlusions of major cerebral vessels in both the anterior and posterior circulation, Bochum, Germany-based Phenox said.
Results indicated a 62.5% rate of positive clinical outcomes with freedom from severe neurological deficits, and an 84.4% rate of vessel recanalization. Mortality rates in the trial were marked at 7%, Phenox said.
“Considering the increased evidence in favor of mechanical thrombectomy and the outstanding results of Artesp, it is vitally important that the pREset thrombectomy device is available for doctors who treat patients with ischemic stroke. In the interest of adding clinical evidence for thrombectomy we are delighted that the pREset and pREset Lite thrombectomy devices are now included, among others, in the SITS open study,” managing partner Dr. Hermann Monstadt said in a press release.
The company said the results “mirrored and reinforced” findings from 4 other randomized controlled trials which examined the efficacy of mechanical thrombectomy procedures.
Last December, Phenox said it plans to open a new manufacturing plant in Galway, Ireland.
Phenox’s new Galway plant is slated to make interventional neurovascular medical devices for the treatment of aneurysms and stroke. Founder & managing director Monstadt told the Irish Times that the facility “will produce products specifically for the U.S. and other international markets as well as provide additional support for EU markets.”