Medical Device Daily

With NOTES (natural orifice transluminal endoscopic surgery) gaining more and more of a foothold in a variety of procedures, Covidien's (Mansfield, Massachusetts) SILS (single-incision laparoscopic surgery) Port Platform is gaining a foothold with not just the FDA, but surgeons and patients alike.

Laparoscopic procedures performed through a single incision are a significant evolution in the world of surgery. While laparoscopy traditionally offers better patient outcomes including less pain and improved cosmesis than the open approach, SILS procedures have the potential to dramatically extend these benefits.

The company reported that the FDA approved the SILS Port yesterday and that there are plans to launch the product between April and May.

"The market is looking for Covidien to lead the field with devices specific for SILS," said Patrick Helfrich, global marketing director for instrumentation. "We expect customers to receive this warmly."

The platform is a single, flexible port that can be fitted through a small incision in the umbilicus which results in a single "hidden scar," a cosmetic advance over the multiple visible scars associated with standard multi-port laparoscopy. The port has the capacity for up to three laparoscopic instruments.

SILS Port is the first device specifically indicated for multiple instrument access to the abdomen through a single incision.

"It potentially leads to a scarless surgery with less pain for the patient," Helfrich said.

Traditional laparoscopic procedures usually take three instruments – and often cause a potential tissue defect.

The port will be involved in a multi-center trial comparing the effectiveness of traditional laparoscopic cholecystectomy procedures and SILS cholecystectomy. The trial, which will be double-blind, is expected to start in February and be in eight to 10 sites throughout the country.

"The SILS port is just one thing we're going to bolster," Helfrich said. "We expect to begin using the product very soon – within the next month."

SILS' increased prominence throughout the last year comes from NOTES, he said. "SILS is looked at as a steppingstone in the evolution of NOTES."

The company said it is actively working with surgeons around the world to develop even less invasive approaches for surgery, including NOTES. In 2007, the company established the Covidien NOTES Research Fund in conjunction with NOSCARTM (Natural Orifice Surgery Consortium for Assessment and Research) to support clinical research in key technological areas of this new form of surgery, including peritoneal access, suturing and anastomotic devices.

Covidien has been on an upward path for the better part of two years now.

Since its separation from Tyco, the company has performed better than expected, according to some analysts. It formally split from Tyco in 2007 (Medical Device Daily, July 6, 2007).

The company reported third-quarter net sales rising 14% to $2.6 billion from $2.3 billion a year earlier, driven by higher volume and new products, and an operating income of $545 million vs. a loss of $761 million in the prior-year period (MDD, Aug. 18, 2008).

For the first nine months of fiscal 2008, sales of $7.3 billion were 11% above the $6.6 billion in the prior year, with operating income of $1.4 billion vs. $199 million a year earlier, and diluted EPS from continuing operations of $2.03 vs. a loss of 86 cents a share in the comparable period.

The goal, Covidien officials say, is to push revenue growth into the mid-single digits within the next few years.

The company launched its Women in Surgery initiative at the American College of Surgeons (ACS; Chicago) meeting in San Francisco (Oct. 21, 2008). The Covidien Women in Surgery program will champion and support current and future female surgeons at all stages of their careers to help address the growing need for surgeons in the U.S., the company said.