No Material Degradation of Balloon Tubing during Interface Catheter Solutions Extrusion Process

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Laguna Niguel, CA, August 19, 2010 – Independent testing by a leading laboratory shows that Interface extrusion process does not result in any degradation of the polymer material after the extrusion process.

“For many manufacturers, breakdown in polymer molecular weight during the extrusion process can lead to the development of structural flaws or gel spots that compromise the integrity of balloon tubing,” says Kenny Mazzarese, director, balloon development for Interface Catheter Solutions. “These new test results confirm our extrusion process does not degrade polymer chains and that the molecular weight of the final extruded product is essentially the same as the raw material. This greatly reduces the possibility of gel spots or other defects during balloon production.”

Six samples of Nylon 12, PEBAX®, and of Nylon 12/PEBAX® blend, both in pellets and the tubing extruded from the pellets were submitted for analysis of their molecular weight distributions before and after extrusion, using gel permeation chromatography (GPC). No significant changes in molecular weights and molecular weight distributions were observed in any of the samples. Testing was conducted by Polymer Solutions Incorporated (Blacksburg VA), an ISO 17025-accredited and FDA-registered polymer testing lab utilized by the FDA and medical device, pharmaceutical, plastic, and drug delivery industries.

Interface Catheter Solutions is the only vertically integrated provider of outsourced solutions for balloon catheter manufacturing. Interface has been solely focused on the balloon catheter market since 1995 and continually sets industry standards through process and equipment advancements in balloon catheter manufacturing.

Interface has created more than 2,000 balloon designs, and offers balloon design and development, extruded balloon tubing, balloon contract manufacturing, plus a comprehensive line of balloon catheter production and testing equipment. Interface is ISO 13485:2003 certified and operates multiple class 10,000 (ISO Class 7) and 100,000 (ISO Class 8) clean rooms in three facilities. Interface’s headquarters is located at 27721 La Paz Road, Laguna Niguel, California. www.interfaceusa.com Tel 949.448.7056.

Company Contacts:

Eric Mabry
Vice President, Sales & Marketing
Tel: 949-448-7056 x7148
E-mail: [email protected]

Ronelle Decker
Marketing Manager
Tel: 949-448-7056 x7151
E-mail: [email protected]

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