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 concentric-medical.
Concentric, Merci and MERCI are trademarks/registered trademarks of
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 acutestroke.
Concentric Medical, Inc.