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2006-02-23 News Headlines

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New hemocompatible Lexan HPM polycarbonate plastics resin grade

ESTECH selects a Hemocompatible Lexan HPM resin from GE Plastics for exceptional reliability in new ClearView mitral valve atrial depressor medical device applications.

GE Plastics has introduced a new surgical device from ESTECH that features GE’s new hemocompatible1 Lexan* HPM 1914 polycarbonate (PC) resin. The latest addition to the Lexan resin portfolio, which is designed to meet the specific needs of the healthcare market.

ESTECH, a California-based maker of cardiac surgery devices, selected the GE material for the paddle of its new single-use ClearView MV™ Atrial Depressor to help achieve a high level of device reliability and biocompatibility2 in minimally invasive mitral valve repair and replacement procedures. For ESTECH and other device manufacturers, GE’s Lexan HPM resins offer the typical strength of PC as well as new capabilities that provide improved hemocompatibility1, reduced protein binding, improved low temperature ductility, and the potential for improved flow and release.

“We consider Lexan HPM resin to be state of the art,” said Mike Banchieri, senior engineer for ESTECH. “The strength of this material gives us confidence that our device will perform reliably during critical heart surgeries, and its hemocompatibility1 goes well beyond the properties of ordinary polycarbonate to improve patient safety. Another important benefit is Lexan HPM resin’s compatibility with gamma sterilization, which helps us speed up production by avoiding the need for lengthy EtO sterilization. We aim to use the best materials for our products, and GE delivered the best.”

ESTECH Chooses GE's New Hemocompatible Lexan* HPM Resin For Exceptional Reliability in New ClearView MV (TM) Atrial Depressor. Click here for High resolution image.

ESTECH, headquartered in San Ramon, Calif, offers tools for least-invasive techniques and traditional approaches to the procedures that cardiac surgeons do every day - coronary artery bypass, valve surgery, atrial ablation, and surgical treatment of congestive heart failure.

The ESTECH ClearView MV Atrial Depressor, which was introduced on Jan. 29, 2006 at the Society of Thoracic Surgeons’ Annual Meeting in Chicago, is a single-use, sterile device that provides exposure of the mitral valve via a paddle and a malleable shaft for retraction of the posterior atrial wall. The device features an integrated suction channel for clearing the atrium of fluid during minimally invasive heart valve surgery. By providing a clear field of view in a confined space, the ClearView MV Atrial Depressor helps surgeons repair or replace the mitral valve accurately and more easily.

Lexan HPM resin enabled ESTECH to significantly improve upon an earlier, reusable version of the device, which was made of stainless steel and required separate steps to attach the suction channel. The use of the GE material enabled part integration for simpler preparation and operation, reduced weight, and eliminated reprocessing procedures, repairs, and the risk of lost parts. Assisting device manufacturers to identify more efficient and easy-to-use products with its highly engineered resins is a top priority at GE.

GE’s Lexan HPM resins offer the typical strength of PC. Click here for High resolution image.

GE’s family of Lexan HPM resins, which have been commercially available for approximately six months, are highly ductile, impact-modified PC copolymers that are excellent candidates for healthcare applications involving direct blood contact or potential protein interaction. They demonstrate advanced hemocompatibility1 vs. standard PC grades across multiple biomarkers and test methods. Lexan HPM resins offer biocompatibility2, good property retention following gamma, steam autoclave (at 121 C), and EtO sterilization, as well as resistance to typical healthcare chemicals. These transparent materials are also available in white.

“GE is investing significant resources to address the changing needs of the healthcare industry, including the trend toward less-invasive surgeries that demand specialized medical devices such as ESTECH’s new depressor,” said Clare Frissora, market director for Healthcare, GE – Plastics. “Innovative resins like our Lexan HPM grades give manufacturers the tools to create designs that help healthcare providers improve patient safety and surgical outcomes, and enhance speed of procedures.”

* Lexan and LNP are trademarks of General Electric Company.
™ ClearView MV is a trademark of ESTECH.
1 Biocompatibility: A representative lot of material tested either by ISO 10993 or USP VI protocol. Test data available via Type I or Type II letter. Type I Letter: Issued for products that have been specifically tested for biocompatibility. Type II Letter: Issued when specific product has not been tested but similar products have been tested for biocompatibility.

Find information about GE Plastics.

Images courtesy of GE Plastics.

Read a recent article: Co-extruded Geloy plastics resin product from GE Plastics now offers Chinese architects and designers creative opportunities for colored window profiles with thermo-insulation.




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