Healthcare Industry News:  Invatec 

Devices Interventional FDA

 News Release - March 31, 2009

Invatec Introduces AMPHIRION DEEP Long Balloon to More Easily Access and Treat Arteries Below the Knee

Recent FDA 510(k) Clearance Extends Invatec’s Balloon Catheter Line

BETHLEHEM, Pa.--(HSMN NewsFeed)--Invatec, a comprehensive innovator of interventional products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Amphirion Deep 150 mm Long PTA Balloon and Tapered 210 mm Long PTA Balloon in the United States. The Amphirion Deep Long Balloons join the preexisting Amphirion Deep family of dedicated below the knee (BTK) PTA catheters, which are specifically designed to reach, access and treat arteries below the knee.

With the introduction of the 150 mm and Tapered 210 mm Long Balloons to the US market, physicians can now reach and treat arteries in the feet more easily than ever before. The 150 mm and Tapered 210 mm Long Balloons are indicated to dilate stenoses in the femoral, popliteal and infra-popliteal arteries, while sharing the same unique design and quality features as the rest of the Amphirion Deep product line. The unique Tapered 210 mm Long Balloon is anatomically-designed to provide more precise balloon-to-vessel conformability in the narrowed and tapered distal regions of the leg and foot.

Krishna Rocha-Singh, M.D., F.A.C.C., director of the Prairie Vascular Institute (Springfield, Ill.) commented, “Deep in the lower limb, below the ankle, the vessels narrow. The design of the Tapered 210 mm Long Amphirion allows the effective treatment of the most distal lesions. The Tapered 210 mm is an exceptional aid in the treatment of this very challenging patient population and greatly welcomed.”

“The availability of the Amphiron Deep 150 mm and 210 mm Long Balloons underscores our commitment to offering a full range of peripheral solutions,” commented Jack Springer, president of Invatec, Inc. “The 510(k) for the 150 mm and unique Tapered 210 mm balloons has allowed us to offer more products to physicians, enabling the treatment of additional patients with BTK disease. For many physicians, the Amphirion has become the product of choice and we are pleased to be able to extend the line to these new lengths.”

The entire Amphirion Deep line is 4 French compatible and has a differentiated shaft diameter designed to promote flexibility and trackability without compromising the balloon’s pushability. Invatec’s Amphirion line also boasts a low-profile, enabling ease of crossability. The Amphirion Deep BTK PTA Balloon Catheter line is now available in the US in diameters of 1.5 – 4.0 mm and 20 – 210 mm in length.

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 polymer processing, metal technology and surface technology. Invatec is vertically integrated with full in-house capabilities to design, develop, manufacture and assemble a complete line of product families focusing on interventional peripheral, coronary and neuro products, which are offered in more than 70 countries. Dedicated to “making ideas come alive,” the company was founded in 1996 by Andrea Venturelli and Stefan Widensohler, and has grown to almost 1,000 employees. For more information, visit www.Invatec.com.


Source: Invatec

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