Subject: FDA
MicroVention® Announces FDA Approval For Neuro Stent Device
ALISO VIEJO, Calif., May 31, 2018 /PRNewswire/ -- MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the LVIS® and LVIS® Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The LVIS® and LVIS® Jr. stents are the first and only stents PMA approved for stent-assisted coil embolization and only the second PMA approved device designed for intracranial aneurysm treatment.
The LVIS® and LVIS® Jr. stents (Low profile Visualized Intraluminal Support) feature a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualization to provide support for even the smallest neurovascular embolization coils for the treatment of wide-necked saccular intracranial aneurysms.
"With their low-profile and consistent visibility, LVIS® and LVIS® Jr. stents expand the treatment options for patients with challenging, wide-necked aneurysms. The pivotal trial shows that these stents are safe and effective for patients with aneurysms that may be challenging to treat with other devices," said Dr. David Fiorella, Professor of Neurological Surgery and Radiology, Director of Neurointerventional Radiology, Co-Director of Stony Brook University Cerebrovascular and Stroke Center and primary investigator of the trial.
The LVIS® and LVIS® Jr. stents have been approved for use in the United States under Humanitarian Device Exemption (HDE) since 2014 and with the PMA approval, LVIS® and LVIS® Jr. stents may potentially be used to treat an increased number of patients.
"The LVIS® and LVIS® Jr. stents address the growing preference of physicians for highly conformable braided stents for aneurysm treatment. Thousands of patients globally have benefited from this technology, and we are pleased to have achieved the most rigorous standard of FDA approval to support our customers' usage," said Richard E. Cappetta, President and CEO, MicroVention, Inc.
An intracranial aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain. Patients who present with a ruptured intracranial aneurysm may suffer a subarachnoid hemorrhage (SAH) and are prone to acute re-bleeding with poor clinical outcomes despite current surgical or endovascular treatment.
For more information regarding the LVIS® and LVIS® Jr. coil assist stents and MicroVention's comprehensive line of platinum and clinically proven hydrogel coils, please visit microvention.com.
About MicroVention, Inc.
Founded in 1997, MicroVention® develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. In 2006, Terumo® Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention® into their family of Companies. Terumo's acquisition of MicroVention® allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases.
Headquartered in Aliso Viejo, California, MicroVention® products are today sold in more than 75 nations through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are located within Aliso Viejo, California, San José, Costa Rica and Saint-Germain-en-Laye, France.
About Terumo Corporation
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers, with over $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician-office use.
Terumo® contributes to society by providing valued products and services to the health care market, and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
Media Contact:
Cathy Demyanovich
Sr. Director, Corporate Communications
MicroVention. Inc. 800-990-8361
+1-714-247-8000
SOURCE MicroVention, Inc.
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