phenox pREset Thrombectomy Device proves to be safe and effective
ARTESp shows 62.5% positive clinical outcome after 90 days
ARTESp (Acute Recanalization of Thrombo-Embolic Ischemic Stroke with pREset®) is a prospective, multicenter, single-arm Post Market Clinical Follow-up study in which the efficacy, the safety and the long-term outcomes of mechanical thrombectomy using the pREset® Thrombectomy Device were evaluated. The study included patients with acute proximal occlusions of major cerebral vessels of both the anterior and posterior circulation.
Such cerebral occlusions are the main cause of ischemic strokes resulting in permanent disability and the second cause of death in the western world. Thrombectomy systems like the pREset® enable the treating physicians to quickly restore blood flow in the patient’s brain, by removing the clot from the artery.
Overall, 100 patients with 109 acute intracranial vessel occlusions were included in the ARTESp study. The average age of the patients was 68.3 years and they presented with a mean NIHSS5 of 15. The rate of vessel recanalization (re-opening) (TICI6 2b/3) was 84.4%. After 90 days, 62.5% of the patients had a positive clinical outcome and were free of severe, neurological deficits (modified Rankin Scale mRS 0-2). The mortality rate was 7%.
“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,” says Dr. Hermann Monstadt, Managing Partner, phenox GmbH. “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.” The SITS Open study under the direction of the neuroscientific department at Karolinska Institute, Sweden, strives to compare the stand-alone use of intravenous clot busting drugs to mechanical thrombectomy. This study hopes to add further evidence for the use of mechanical thrombectomy as a first line and standard of care treatment for proximal large vessel occlusion ischemic strokes.
The results of the ARTESp study were published in the following paper:
Prothmann et al.; Acute Recanalization of Thrombo-Embolic Ischemic Stroke with pREset (ARTESp): the impact of occlusion time on clinical outcome of directly admitted and transferred patients; J NeuroIntervent Surg 2016; doi:10.1136/neurintsurg-2016-012556.
1Berkhemer et al.; A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke; N Engl J Med 2014; DOI: 10.1056/NEJMoa1411587.
2Saver et al.; Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke; N Engl J Med 2015; DOI: 10.1056/NEJMoa1415061.
3Campbell et al.; Endovascular Therapy for Ischemic Stroke with Perfusion-Imaging Selection; N Engl J Med 2015; DOI: 10.1056/NEJMoa1414792.
4Goyal et al.; Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke; N Engl J Med 2015; DOI: 10.1056/NEJMoa1414905.
5NIHSS = NIH Stroke Scale
6TICI = Thrombolysis in Cerebral Infarction
Since its founding in 2005, phenox has been dedicated to developing innovative, breakthrough and clinically proven technologies and solutions for the treatment of neurovascular diseases. phenox's products are used by endovascular specialists to treat ischemic and hemorrhagic stroke. The company offers a growing portfolio of innovative treatment options, including the primary interventional technologies used today – the pREset and pREset LITE Thrombectomy Retriever, the p64 Flow Modulation Device and the pCONus Bifurcation Aneurysm Implant. phenox is a privately held company financed with private funds and by NRW. BANK. Venture Fond GmbH & Co.KG. together with SHS Technologiefonds GmbH & Co.KG. More information about the company and its products can be found at www.phenox.net.
The pREset Thrombectomy Device is not approved for sale nor is it available for sale or use in the United States.
phenox, pREset, pCONus, p64 and p64 Flow Modulation Device are trademarks of phenox GmbH, registered in Germany and other countries. All other trademarks and trade names referred to in this press release are the property of their respective owners.