Global Vascular Interventional Leader InvatecLaunches U.S. Operations

Trial for embolic protection device underway; PTA balloon product line and thrombus management catheter available in United States

Invatec available at Booth 43 at VIVA Conference

LAS VEGAS--(BUSINESS WIRE)--Invatec, a comprehensive innovator of vascular interventional products with global headquarters based in Italy, today announced 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.

“I am excited to be joining Invatec, a company deeply invested in collaboration with physicians for the research and development of new vascular and non vascular products,” commented Springer. “Our launch in the U.S. represents a tremendous opportunity to expand our strong base and to develop innovative new products with the input of some of the world’s leaders in endovascular medicine.”

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 IDE (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, MD (Riverside Methodist Hospital, Columbus, OH) and L. Nelson Hopkins, MD (University of Buffalo, Buffalo, NY).

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

* Amphiron Deep™ 0.014” PTA Balloon Catheter – the first dedicated below the knee PTA catheter * Submarine Plus™ 0.018” PTA Balloon Catheter * Admiral Xtreme™ 0.035” PTA Balloon * Diver ce 0.014” RX Clot Extraction Catheter

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.

About Invatec

Invatec is a comprehensive innovator of vascular interventional products with global headquarters based in Italy. Driven by research and technology, Invatec actively collaborates with physicians and centers of excellence to develop products that will improve life expectancy and quality of life for patients. The company’s core competencies include plastic processing, metal technology and surface technology. Invatec is vertically integrated with full in-house capabilities to design, develop, manufacture and assemble the 35 product families that are offered in more than 70 countries. Dedicated to “making ideas come alive,” the company was founded in 1996 by Andrea Venturelli and Stefan Widensholer, and has grown to more than 700 employees. For more information, visit www.invatec.us.

Contacts

For Invatec Andrea tenBroek/Cassie Wallace, 781-684-0770 invatec@schwartz-pr.com

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