Concentric Medical And The SITS Network Announce Partnership To Initiate Clinical Study On Merci(R) Retrieval System

Main Category: Stroke / Neuroprotection
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 16 May 2006 - 0:00 PDT

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Concentric Medical, Inc. and the SITS Network today jointly announced their partnership on the THRUST (Thrombectomy in Unsuccessful Stroke Thrombolysis) study. The study will be sponsored by Concentric Medical and managed by the SITS Network. The study is anticipated to begin enrolling patients later this year, and Concentric Medical and SITS are actively recruiting sites to participate. Experience with the Merci(R) Retrieval System, documented in the SITS thrombectomy registry, is required for participation.

The THRUST study will investigate the Merci Retrieval procedure in ischemic stroke patients who fail standard thrombolytic therapy. It is estimated that about one third of patients with intravenous thrombolysis have not improved two hours after the start of treatment. Further, the prognosis of this group of patients is poor in comparison to those who demonstrate some degree of improvement. The Merci Retriever is indicated for use in patients who fail standard lytic therapy, and mechanical thrombectomy with the Merci Retrieval procedure may offer substantial benefit for these individuals. THRUST will compare, in patients who fail to improve on intravenous thrombolysis, the clinical outcome of patients treated with mechanical thrombectomy using the Merci Retrieval System versus patients with no further intervention.

The Merci Retrieval System has been marketed in the U.S. since 2004, based upon data gathered during the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) trial. The Merci Retrieval System also has earned the European Union's CE mark. The results of the MERCI trial were published in Stroke in July 2005. More recently, interim results from the ongoing Multi MERCI trial (presented at the International Stroke Conference, February 2006) provide further evidence of the benefits of the Merci procedure in failed thrombolysis patients.

"We believe that restoring blood flow quickly is key in a devastating stroke, and that restoration of flow correlates with good outcomes," said Gary Curtis, President and CEO of Concentric Medical. "We look forward to working with the international stroke community, through the SITS Network, to provide further clinical evidence to support the use of the Merci Retrieval System."

"The THRUST study is an important step in providing practitioners with additional treatments in stroke," said Professor Nils Wahlgren, Chairman of SITS International. "There has been a high interest from members within the SITS Network to participate which shows the importance of this study."

About Concentric Medical

Located in Mountain View, California, and founded in 1999, Concentric Medical is committed to opening the pathway to new stroke treatments. The flagship product line, Merci(R) Retriever, is indicated for use in removing blood clots from the brain in patients suffering an ischemic stroke. The Merci procedure is currently being performed in over 180 centers around the world, and Concentric Medical estimates that over 3,000 patients have been treated with the device. More information about Concentric Medical and its products can be found at http://www.concentric-medical.com.

Concentric, Merci and MERCI are trademarks/registered trademarks of Concentric Medical.

About the SITS Network

The SITS Network is the world's largest stroke network covering more than 500 stroke clinics in more than 30 countries on four continents. The SITS Network is an optimal vehicle for clinical/post-launch studies and registries in stroke. The objective of the SITS Network is the broad implementation and amplification of evidence based stroke treatments. More information about the SITS Network can be found at http://www.acutestroke.org.

Concentric Medical, Inc.
http://www.concentric-medical.com