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21st February 2006

NDO Surgical's treatment for GERD gets a new kick with innovative technolgy from Cambridge Consultants

• Redesign extends the life of NDO Surgical's flagship laparoscopic surgery device for GERD as manufacturer pushes to expand the market

Cambridge Consultants is working with NDO Surgical, the Mansfield, MA, medical device maker, to apply novel technologies to extend the time between service for its award-winning endoscopic device, which treats heartburn and other effects of gastroesophageal reflux disease (GERD). With non-invasive procedures to treat GERD making significant gains in market acceptance in the US, the enhancements to NDO Surgical's Full-Thickness Plicator™ system allow the company to better compete in the estimated $9.3 billion US market - with a more rugged device that is capable of longer life in the field.

The existing Plicator device, which was first approved by the FDA in 2003, has received enthusiastic adoption by surgeons as the endoluminal therapy of choice, and has begun displacing other GERD treatment options because of the device's ease of use and clinical performance. GERD is a catch-all condition referring to assorted symptoms including heartburn, regurgitation, chest pain, hoarseness, wheezing and coughing due to tissue damage from the chronic reflux of stomach contents into the esophagus.

Rather than requiring surgery, the NDO Surgical Plicator allows physicians to enter the stomach, via the esophagus, then flex and accurately position an implant at the gastroesophageal junction, restoring the anti-reflux barrier. No incisions are required and the procedure is performed under conscious sedation. In a multi-center clinical study involving treatment with the Full-Thickness Plicator system, patients experienced sustained and significant improvement in GERD symptoms, medication use reduction, and distal esophageal acid exposure.

With increased market penetration and improving sales, NDO Surgical wanted to extend the lifetime of each instrument to support an increased number of safe and reliable uses before the need for instrument refurbishment. In late 2005 the company turned to Cambridge Consultants to investigate novel materials, designs, and processes to optimize the lifespan and extend functionality in the field.

Improved Seals Enhance The Device

While the Plicator implant concept is ingenious in its simplicity, the delivery device is a complex system. The Plicator uses many design features of endoscopes employing flexible joints and controls so that physicians can introduce it through a patient's throat and manipulate it once inside the stomach. The device consists of many linkages, pulleys and levers that are assembled and covered by several polymeric sealing boots. The boots and their joints must remain liquid-tight, and retain their flexibility under repeated exposure to aggressive disinfection solutions at elevated temperatures, while not adding any additional resistance or bulk to the working mechanisms of the device.

Cambridge Consultants prototyped, tested and developed approaches such as RF (radio frequency) and laser welding, as well as optimizing mainstream techniques, such as solvent bonding, for improving the seals protecting the underlying mechanisms of the Plicator device. All recommendations were made with an eye to meeting FDA biocompatibility requirements. Simultaneously, the firm modified NDO Surgical's original design in areas around the joints where the boots come together to accommodate the unique requirements of each of the sealing methods. Cambridge Consultants also provided CAD models, detailed drawings, production system specifications, adhesives selections and solvent bonding recipes for NDO Surgical's ownership and use going forward.

Results to date are extremely promising. NDO Surgical anticipates a reduction in manufacturing cost as well as a reduction in device returns for refurbishment. All improvements are expected to be introduced to the market in 2006.

"Although we have a design that works well, we engaged Cambridge Consultants to push the envelope in these critical areas," said Tom Bromander, vice president, Engineering at NDO Surgical. "Their contribution will translate to an improved, more reliable product which translates directly to the bottom line. Safety and reliability at a lower cost is what we were looking for. Cambridge Consultants understood our requirements and were able to improve our business through innovation."

"With several decades of expertise in medical device product design, Cambridge Consultants has a vast understanding of key technologies that companies like NDO Surgical can employ for the utmost in successful products," said Andrew Diston, senior vice president and managing director of Cambridge Consultants' Boston office. "We were delighted to work to help NDO's team meet their goals of keeping their Plicator instrument in the field longer, under heavy use with less maintenance."

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