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Medical Device Daily Senior Staff Writer

Surgeons should be getting a couple new tools to be excited about in the not-too-distant future – a flexible vessel sealer and a flexible stapler from TransEnterix (Research Triangle Park, North Carolina).

The company, which recently reported raising $15 million, told Medical Device Daily Tuesday in an exclusive first interview that it is using those funds to develop a flexible vessel sealer and a flexible stapler to be used with the TransEnterix Spider system.

Currently, the system includes access tools and surgical instruments but the markets for vessel sealers and staplers are dominated by Johnson & Johnson (J&J; New Brunswick, New Jersey) and Covidien (Mansfield, Massachusetts).

"For us, if we really want to compete against J&J and Covidien, we feel like we need to have the entire product category (in laparoscopic surgery," Todd Pope, president/CEO of TransEnterix, told MDD. "Right now we have two, access and instruments."

Pope said the vessel sealing market is currently estimated to be more than $2 billion, while stapling is a $3 billion-plus market.

The TransEnterix Spider (single port instrument delivery extended reach) surgical system gives surgeons 360-degree motion in a device the diameter of a dime. Once inside, the Spider opens like an umbrella giving surgeons the flexibility and capability to perform a variety of abdominal procedures. The single incision reduces patient scarring and also means quicker recovery time.

The SPIDER became commercially available in the U.S. in early 2010 (MDD, April 12, 2010) and later that year TransEnterix received the CE mark, clearing the way for market entry into Europe (MDD, Oct. 22, 2010).

The company launched a new version of the Spider surgical system last year (MDD, May 11, 2011). In addition to the increased strength for dissecting and retracting tissue, TransEnterix says the new Spider system delivers added precision through new endomechanical arms that move and control instruments, improved ergonomics through a modified surgeon interface, and optimized reach for a wide range of patient types and operative tasks. The ability to vary reach within the abdomen is particularly important in minimally invasive surgeries to treat obesity, like gastric banding and sleeve gastrectomy, the company noted.

The system is designed to address problems that surgeons frequently encounter when using other, less-sophisticated single-incision systems by opening up and expanding within the patient's abdomen, like an umbrella. According to the company, this allows surgeons to readily triangulate instruments and safely accomplish many tasks from one small incision.

"Ultimately, when we started the company four years ago we wanted to create a new category in surgery . . . what we hoped to do is take the concept of long flexible instruments and really replace many of the long laparoscopic instruments that were rigid," Pope told MDD. "Less invasive medicine has driven so much of what is out there in advancements in surgery over the years and we just haven't had a lot of movement over the last twenty years in laparoscopic surgery."

Pope said development on both products is already underway and the company hopes to launch one of the new products in 2013, after going through the FDA 510(k) process.

TransEnterix's recent $15 million financing (MDD, Dec. 16, 2011) represented the second tranche of the company's Series B round from 2009 when it raised $55 million, paving the way for the company to manufacture and market the Spider surgical platform (MDD, Oct. 8, 2009). The company's total venture raised is now about $91 million.

"This investment we just raised was 100% from insiders," Pope said. "That sends a strong message when you have investors and are totally able to support your latest round . . . it's a vote of confidence."

Pope said more than 1,500 procedures have been performed using the current Spider system in the U.S. and Europe.

Published  January 4, 2012

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