April 2, 2009 – Invatec received 510(k) clearance from the FDA to market its Amphirion Deep 150 mm Long PTA Balloon and Tapered 210 mm Long PTA Balloon in U.S.
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 U.S. market, the company said 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.
“Deep in the lower limb, below the ankle, the vessels narrow,” said Krishna Rocha-Singh, M.D., FACC, director of the Prairie Vascular Institute in Springfield, IL. “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 entire Amphirion Deep line is 4 Fr. compatible and has a differentiated shaft diameter designed to promote flexibility and trackability without compromising the balloon’s pushability.
For more information: www.invatec.com