Reverse Medical Corporation Receives FDA IDE Clinical Study Approval For The ReStoreTM Microcatheter

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Stroke
Article Date: 25 Sep 2009 - 21:00 PDT

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Reverse Medical Corporation announced today that it has received US Food and Drug Administration (FDA) conditional approval to begin a neurothrombectomy IDE study for its ReStore™ Microcatheter at twenty US centers. The study is planned to begin enrollment in US and European hospitals following investigating study center Institutional Review Board (IRB) approvals. Study enrollment will involve approximately 120 subjects which present within eight hours from symptom onset.

Commenting on this significant regulatory milestone, Reverse Medical's Chief Executive Officer Jeffrey Valko said, "This conditional IDE approval of the Reverse Medical ReStore™ Microcatheter represents another important strategic step forward for our rapidly growing Company. We will begin patient enrollment early in 2010, following IRB approvals from our investigating study centers. Reverse Medical will continue to pursue a broadening platform of state-of-the-art endovascular devices for the treatment of neurovascular disorders."

Reverse Medical's scientific and clinical advisor Dr. Satoshi Tateshima, MD, D.M.Sc., Division of Interventional Neuroradiology and UCLA Stroke Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA stated, "In the US, roughly 50% of acute stroke interventions are performed with clot retrievers, and the remainder from a combination of angioplasty, clot aspiration, stenting, and thrombolytic drug delivery. My personal opinion is that the Reverse Medical technology versatility will allow the ReStore™ Microcatheter to cover all of those cases that are currently treated with clot retrievers, suction devices, angioplasty devices and stents."

Reverse Medical has established a strong patent position that surrounds these technology platforms and currently holds one issued and three published US patent applications with an additional nine US patent applications pending publication.

Source
Reverse Medical Corporation