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69.4% Of Ischemic Stroke Patients Had Blood Flow Restored In Multicenter Trial

September 26, 2017

Ischemic stroke patients treated in the Multi MERCI trial experienced blood flow restoration rates of 69.4%. Additionally, one out of three ischemic stroke patients was functionally independent at 90 days following this procedure. Interim results of the Multi MERCI (Part 1) trial were reported today at the International Stroke Conference, Kissimmee, FL, by Wade Smith, MD, PhD, Principal Investigator and Associate Professor of Neurology, University of California, San Francisco.

In the Multi MERCI trial, the primary treatment options were the current and next generation Merci(R) Retrievers. The 69.4% blood flow restoration rate seen in the Multi MERCI trial represents a 15% relative improvement for patients compared with those treated in the previous trial. Clinical outcomes for severe stroke patients treated were also improved as demonstrated by 34.3% of patients treated reporting a Modified Rankin Score of < / = 2 (or functional independence) at 90 days.

The Merci(R) Retriever is the only medical device cleared by the FDA to remove blood clots from the brain in patients suffering an ischemic stroke. "These interim results offer further support of the Merci(R) Retriever's ability to safely restore blood flow for these patients with devastating strokes, including those patients where prior clot dissolving drug treatment (IV t-PA) was not effective," said Wade Smith, MD, PhD. "This restoration of flow provides them with the potential of favorable clinical outcomes and over a third of these patients are now living functionally independent lives."

The Merci Retriever is a "corkscrew-type" device that is delivered into the brain using standard catheterization techniques. A small puncture in the groin is used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is designed to restore blood flow by engaging, capturing and removing the blood clot.

The study results were obtained from a multi-center, prospective trial including 111 patients treated at 14 hospitals in the United States and Canada. All patients had moderate-to-severe, large vessel strokes. When looking at the natural history, the prognosis for many of these stroke patients is poor with the rate of death ranging from 35 to 90%. In addition, patients studied in the Multi MERCI trial could be ineligible for or had failed treatment with a clot-dissolving drug called t-PA. Many of these large vessel strokes have a large clot burden, which may make it difficult for clot- dissolving drugs to be effective without added risk. Treatment was initiated within eight hours of stroke symptom onset, which is beyond the three-hour treatment window for intravenous clot-dissolving drugs. The Merci(R) Retrieval System offers the longest time window for patients suffering an ischemic stroke.

Stroke is the number one leading cause of disability and is the third leading cause of death in the United States. Of the 750,000 annual strokes in the US, approximately 85 percent are ischemic. An ischemic stroke occurs when a blood vessel in the brain is blocked by a blood clot, which can impair brain function and cause severe disability or death. Approximately every 45 seconds, someone in the United States has a stroke. This risk of having a repeat stroke is ten times greater for stroke survivors than the general population. "Our belief has been that restoring blood flow quickly is key in a devastating stroke. Restoration of flow correlated with good outcomes for many of these patients," said Gary Curtis, President and CEO of Concentric Medical. "We are committed to changing and improving the way in which ischemic stroke patients are treated, and continue our efforts on newer generation devices."

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 the only medical device cleared by the FDA to remove blood clots from the brain in patients suffering an ischemic stroke. concentric-medical