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phenox GmbH Lise-Meitner-Allee 31 44801 Bochum, Germany http://www.phenox.net/
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SITS Open stroke trial includes pREset Thrombectomy Device by phenox GmbH

(PresseBox) (Bochum, phenox GmbH, )
phenox GmbH, announces participation in the SITS Open clinical trial where pREset and pREset LITE Thrombectomy Devices have been included in the study device portfolio, one of only three devices to be used in the study.

Stroke is the second leading cause of death worldwide and the most common cause of adult disability in the western world. Ischemic stroke, caused by a blocked artery, is the most common type of stroke and it takes only minutes without oxygen for brain damage to occur and more brain cells die every minute that flow is blocked. The aim of physicians is to restore blood flow by opening the blocked artery as quickly as possible thereby enhancing the patient’s survivability and prevent long lasting disability.

The positive outcomes of recent randomized clinical trials for mechanical thrombectomy such as MR CLEAN, ESCAPE, EXTEND IA and SWIFT PRIME have renewed interest in studies enrolling a large number of patients - studies such as SITS Open. The SITS Open protocol is designed to provide a higher level of evidence for mechanical thrombectomy through a direct comparison between mechanical thrombectomy and a concurrent control of medical management alone.

According to the Department of Neuroscience at Karolinska Institute (Stockholm, Sweden), sponsors of the trial, 194 patients are enrolled in the open, prospective, international, multicenter, controlled clinical trial as of today. The protocol calls for enrolling 600 patients in total, 300 in each arm. Patients enrolled in the treatment arm will be done so at centers that currently perform thrombectomy for stroke and fulfil the quality and training criteria for neuro-interventions. Patients in the control arm will be enrolled by clinics that offer IV thrombolysis and neither practice thrombectomy nor refer patients with ischemic stroke to other clinics where thrombectomy is offered.
phenox’ Managing Director, Dr. –Ing Hermann Monstadt said, “given the growing evidence regarding the effectiveness of mechanical thrombectomy, it is very important that pREset and pREset LT are a part of the tools available to physicians in treating ischemic stroke.”

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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.info 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.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.