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Positive First-in-Man Results With New Laparoscopic Surgical Platform

Tue, 09/01/2009 - 5:49am

RESEARCH TRIANGLE PARK, N.C.-- (BUSINESS WIRE) — Aug. 31, 2009--Officials with TransEnterix announce that surgeons from the United States and Paraguay have successfully performed first-in-man studies of its revolutionary single-incision, single-port, four-channel laparoscopic surgical platform called the SPIDER™ System.

The SPIDER System - short for Single Port Instrument Delivery Extended Reach - allows surgeons to perform minimally invasive abdominal surgeries entirely through the umbilicus, leaving no visible scar. It's the first single-port system to offer surgeons true triangulation and other critical techniques common in multi-port laparoscopy.

Fewer complications, faster full recovery, less post-surgical pain and an improved aesthetic result are potential benefits of single-port technology. Conventional laparoscopic surgery typically involves three to five incisions, which leave small scars in a patient's abdomen. Surgeons in the United States perform more than 2.5 million laparoscopic procedures each year. TransEnterix expects to market its platform early next year.

In the TransEnterix first-in-man studies, surgeons successfully used the SPIDER System to perform cholecystectomies - gallbladder removals - on seven patients in Paraguay. One of the surgeons was American; the other surgeon was Paraguayan. The patients were Paraguayans who previously had received medical diagnoses requiring surgical removal of their gallbladders.

Todd M. Pope, president and CEO, said the procedures went extremely well, adding that surgeons confirmed that cholecystectomies performed with the SPIDER System took approximately the same amount of time as standard laparoscopic procedures.

"And that's a critical point to make because surgeons won't be interested in new technology that requires that they spend more time in the operating room - technological advances should make their jobs easier, not harder," Pope said. "As we knew from having worked so closely with TransEnterix's expert surgeon advisers, the SPIDER System is extremely user friendly. Surgeons who are comfortable with current laparoscopic techniques will adapt easily to our new platform."

Dr. Aurora Pryor, a surgeon who serves on the TransEnterix Scientific Advisory Board, oversaw the first-in-man studies in Paraguay. She said the SPIDER System performed exactly as expected.

"I was pleased with how straightforward the system was to set up and use," she said. "Two of the patients had acute inflammation and with the SPIDER System, I was able to complete their procedures safely and efficiently. The post-operative results were excellent -the patients' scars were hidden and the patients reported less pain than is typical with standard laparoscopic approaches."

Dr. Hector Rolando Herrera Cabral is the Paraguayan surgeon who performed two of the cholecystectomies during the first-in-man studies. Despite never having seen the SPIDER System before participating in the TransEnterix first-in-man cases, the surgeon said he was quickly able to use it.

"My experience was very positive," he said. "What was most impressive is how patients who had a cholecystectomy with the SPIDER System did not report any pain the day after the surgery or said their pain was minimal, whereas patients who undergo conventional laparoscopic surgery typically report mild pain. The aesthetic result is fantastic - the wound heals without leaving marks on the abdomen - and patients report total satisfaction."

TransEnterix partners with the world's leading physicians to rapidly develop pioneering technologies that revolutionize minimally invasive surgery. The company relies on rapid prototyping, intense pre-clinical labs and hands-on collaboration with expert surgeons to accelerate learning and bring a device to market more quickly. TransEnterix has secured $21 million in Series A venture capital funding.

To learn more about TransEnterix, visit online at www.transenterix.com.

To learn more about the SPIDER System and to see how it works, visit www.truesingleport.com.

 

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