With a single incision in the navel, Jihad Kaouk, MD, director of robotic urologic surgery at Cleveland Clinic has performed the first radical prostatectomy and radical urinary cystectomy (cystoprostatectomy) using a handy new laparoscopic tool.

Conventional laparoscopic approaches use up to six abdominal wall incisions. Kaouk used the Uni-X Single Port Laparoscopic System, developed by Pnavel Systems (Brooklyn, New York) without any additional incisions. The technology was developed by Gregory Piskun, MD, a private practice laparoscopic surgeon who nine years ago decided that conventional instruments were inappropriate for this new surgical approach.

“I published a paper in 1999 on laparoscopic gallbladder surgery using no incisions outside of the umbilicus,” Piskun told Medical Device Daily. “We used conventional instruments. The surgery was technically difficult although successful. For the last nine years, I’ve been working to develop this technology.”

Piskun developed the Uni-X Single Port Laparoscopic System through Pnavel, a company he said has remained “below the radar screen. We’re working to commercialize the technology and we’re in the process of manufacturing a large quantity for further study and commercialization.”

Piskun said that although Pnavel has sufficient funding to continue development and prepare for commercialization, he is in the midst of talks with several larger manufacturers for a potential alliance. “We’re also in the process of getting venture capital funding to scale up. We have outsourced most of our activities to date. We’re really a small virtual company right now.”

Kaouk has successfully performed more than 25 urological reconstructive, ablative and excisional operations with this new approach. Those procedures include, among others, kidney tumor cryoablation and radical nephrectomy.

He also used the single port technique to perform the first single port retroperitoneal kidney surgery and single port laparoscopic pediatric surgery. In October, Kaouk performed the first sacral colpopexy entirely through a single belly button incision using the Uni-X system. The minimally invasive sacral colpopexy is designed to repair vaginal vault prolapse which may occur after previous hysterectomy. An abdominal sacral colpopexy is traditionally performed via a large lower abdominal incision or several small abdominal incisions.

To date, no intra-operative or postoperative complications have been reported. There were no conversions to conventional laparoscopic approaches or to traditional open procedures either.

This initial experience in the single port laparoscopic method by Kaouk and his colleagues at the Cleveland Clinic will be presented at the American Urological Association (Linthicum, Maryland) meeting in May 2008.

The Uni-X system consists of a single multi-cannula laparoscopic port and a variety of curved laparoscopic instruments and eliminates the need for additional abdominal wall incisions and laparoscopic ports. It is currently registered with the FDA as a Class I device.

“We want to further evaluate our technology with surgical leaders and get feedback to improve it,” Piskun said. “We also plan to do more extensive studies. We’ve successfully crossed through most of the development obstacles at this point. Now, we need to explain the benefits to surgeons. It’s obvious from the patients’ perspective. It will be a patient-driven surgical approach because we will offer many patients scarless results from operations.”

Although he said it is premature to estimate the cost of a Uni-X system, Piskun believes it will offer substantial cost savings compared to conventional technology.