News | September 22, 2008

Invatec Opens U.S. Operations, Involved with FDA Brain Embolization Trial

September 23, 2008 – Italian-based Invatec today said at the annual VIVA (Vascular InterVentional Advances) conference that it has formally launched U.S. operations.

Located in Bethlehem, PA, the U.S. headquarters is responsible for the sales, marketing, clinical, regulatory and distribution of the company’s minimally-invasive diagnostic and therapeutic products. These products are used by interventional cardiologists, radiologists, vascular surgeons and other vascular specialists. The company also announced that it has appointed Jack Springer as president to lead U.S. operations.

Springer joins Invatec with more than 15 years of experience in endovascular therapies. He began his career in sales at Abbott Labs before joining Cordis Endovascular, where he worked for 12 years in positions of increasing responsibility leading to his appointment as General Manager for Cordis Endovascular. Most recently, he served as president and CEO at Neuromonics.

Invatec currently has a pivotal investigational device exemption clinical trial known as ARMOUR underway to assess the safety and efficacy of a proximal protection device, Mo.Ma, for use in carotid stenting with FDA approved carotid stents. Mo.Ma protects the brain from embolization by two highly compliant atraumatic balloons, blocking antegrade blood flow from the CCA (Common Carotid Artery) and retrograde blood flow from the ECA (External Carotid Artery). Importantly, protection is established before the critical phase of lesion crossing. Since its first introduction in the European market in 2001, the safety and performance of the Mo.Ma system has been reported in multiple clinical studies outside of the U.S., which also showed broad applicability in standard to complex cases with unmatched high level of technical success.

The study is enrolling patients at 25 investigational sites in the U.S. and Europe under the guidance and supervision of principal investigators Gary Ansel, M.D., Riverside Methodist Hospital, Columbus, OH, and L. Nelson Hopkins, M.D. University of Buffalo, Buffalo, NY.

Invatec, which offers 35 product families in 70 countries worldwide, offers a full PTA balloon product line and a thrombus management catheter available for sale in the U.S.

Invatec has also filed an IDE application seeking FDA permission to begin clinical investigations for an iliac stent. The company also plans to initiate several more clinical trials over the next three years.

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