GE’s Ultem* Resins Contribute Strength & Biocompatibility to Unique, Award-Winning Surgical Skin Stapler

Improving Patient Safety and Comfort

Using two grades of GE’s Ultem* resin in seven components of its INSORB®|20 subcuticular skin stapler, Incisive Surgical, Inc. created a first-of-its-kind device that helps improve surgical outcomes while avoiding the risk of needle sticks for patients and clinicians.

The use of subcuticular absorbable skin staples for closing incisions dramatically improves surgical outcomes while enhancing patient safety and comfort. These staples combine the superior cosmetic results of absorbable sutures with the rapid closure times of metal skin staples – while eliminating the need for post-operative staple removal. To create and perfect its disposable INSORB|20 skin stapler, Minnesota-based Incisive Surgical, Inc., worked closely with GE Advanced Materials for more than 18 months. Incisive Surgical selected two grades of GE Ultem polyetherimide (PEI) resin to help provide strength, sterilization capabilities, and biocompatibility in custom colors for a number of critical components.

GE Plastics and Incisive Surgical

When Incisive Surgical, Inc., a privately-held, emerging medical device company, began developing the INSORB|20 skin stapler, the company turned to GE Plastics for guidance in identifying resins with specific properties required by the new device. The INSORB|20 stapler, which deploys up to 20 subcuticular, absorbable staples, needed high mechanical strength in its nose, arm, and yoke components due to the force of compression during use. Further, these components needed broad sterilization capability – both ETO and gamma – and had to retain strength and color afterwards. Biocompatibility in custom colors and part consolidation were also important characteristics. Working with GE, Incisive Surgical selected GE’s Ultem 1000F unfilled resin and Ultem 2200 glass-filled (20percent) resin for their ability to deliver all these properties, plus excellent aesthetics.

David Stoen, Vice President of Operations for Incisive Surgical, stated, “GE Plastics provided invaluable assistance by showcasing different material options for us to choose from at an early stage in the development process. GE clearly understands the needs of its customers – large and small – and the healthcare industry. GE’s resources, expertise, and services such as custom color-matching helped us achieve a first-of-its-kind product.”

In addition to proposing material candidates, GE provided the company with Color Express* color-matching, expedited material delivery and ongoing support throughout the development process.

The INSORB|20 skin stapler is available nationwide. To date, it has been used in over 3,000 cases and has won several honors, including a 2005 Medical Design Excellence Award and a 2004 Tekne Award. The new device eliminates painful staple removal and doctors benefit from speed and ease of use. In addition, the use of staples instead of sutures avoids the risk of potentially dangerous needle sticks to both caregivers and patients.

"The success of the INSORB|20 Surgical Skin Stapler program is a great example of how GE seeks to align with customers to assist in the development of their applications,” said Clare Frissora, Market Director - Healthcare for GE Plastics. “It is very rewarding for us to see this innovative device come to life, knowing that we were able to assist with the selection of materials from our broad healthcare portfolio and to provide other needed support capabilities."

GE’s Ultem resin is an amorphous thermoplastic polyetherimide offering outstanding high heat resistance, high strength, modulus and broad chemical resistance. Its balance of properties and processability offers design engineers exceptional flexibility and freedom to innovate.

Details at: www.insorb.com

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