BAYSTATE MEDICAL CENTER PHYSICIANS PERFORM WORLD’S FIRST COMPLETELY INCISIONLESS STAPLED ANASTOMOSIS

| June 25, 2007

The ground-breaking NOTES™ approach through the mouth, facilitated by a computer-powered instrumentation platform, provides a revolutionary and less invasive way to perform traditional surgical procedures

SPRINGFIELD – Heralding the dawn of a new age in surgical technology, a team of Baystate Medical Center physicians announced today (July 12) that they have performed the world’s first reported stapled NOTES™ cyst-gastrostomy to successfully treat and save the life of a seriously ill patient who had been hospitalized for months with a chronic pancreatic infection, without the need for an abdominal incision.

The emerging field of NOTES™ (Natural Orifice Translumenal Endoscopic Surgery) is a cutting edge surgical and gastroenterological approach which involves passing flexible surgical tools and a camera through the patient’s natural orifices to eliminate incisions, resulting in less pain, infection, and quicker recoveries. In addition, many patients who are high risk candidates for surgery may be able to be treated with this new less invasive surgical approach.

Traditional methods including the use of stents to treat the patient, 72-year-old Eugene LaFlam of Brattleboro, Vermont, had failed and other medical complications did not make him a good candidate for either open or minimally invasive surgery. As a result, the surgical team performed the innovative procedure on LaFlam on June 26 at Baystate Medical Center utilizing only the patient’s mouth, enabled by a computer powered surgical stapling system from POWER MEDICAL INTERVENTIONS®, Inc. of Langhorne, PA.

“Our team’s researching of NOTES™ at the hospital for the past year and our tracking of the development on the market and our subsequent experimentation with the new flexible power medical stapler, as well as the desire to perform as minimally-invasive surgery as possible on the patient due to his deteriorating condition, all combined in our decision to perform the new innovative procedure on Mr. LaFlam,” said Dr. John Romanelli, FACS, director, Bariatric Surgery, Baystate Medical Center. Romanelli, a longtime pioneer in the field of minimally-invasive surgery, performed the surgery along with the assistance of Dr. David Desilets, chief, Gastroenterology at the hospital.

LaFlam has been hospitalized since February with a chronically infected cyst of the pancreas, likely brought about by a gallstone. He was transferred to Baystate Medical Center from a Vermont hospital where a surgeon there was familiar with Romanelli’s surgical expertise. During his hospitalization, small stents or “drains” were placed through an endoscope, connecting the stomach to the infected cyst for drainage of the cyst’s contents. The large size of the cyst and severity of the infection rendered the stent’s ineffective in draining and clearing the life-threatening infection, which persisted despite the use of the stents and several highly-potent antibiotic regimes over months of treatment.

According to Romanelli, a surgical procedure with abdominal incisions typically would have been performed to create a large, stapled “link” between the pancreatic cyst and stomach. In this case, the location of the cyst made a traditional surgical approach impossible, and the patient’s weakened immune system and decreased ability to heal made even laparoscopic surgery risky, despite the small incisions used.

During the NOTES™ procedure, a computer powered surgical stapler from POWER MEDICAL INTERVENTIONS® was passed through LaFlam’s mouth and into his stomach alongside a small endoscopic camera. Utilizing a remote control unit, the stapler was positioned and fired, resulting in a connection between the cyst and the stomach, creating a large “pathway” through which the infected pancreatic cyst fluid could drain harmlessly into the stomach in order to clear the infection.

LaFlam recovered quickly and had no pain or other complications. After being fed intravenously for several months prior to the procedure, LaFlam began eating clear liquids two days after the procedure. Other critical vital signs, including his white blood count (a sign of infection) dropped significantly for the first time in over a month, a sign that he was recovering quickly.

After re-examining LaFlam with an endoscope six days after the procedure, Desilets said he was thrilled with the results and happy to have good news for their patient.

“The anastomosis was wide open, and the cyst was almost completely gone along with all the dead tissue and clot which had been previously observed. The use of the POWER MEDICAL INTERVENTIONS computer mediated flexible stapling technology to perform NOTES procedures like this will reduce the risk of surgery for many patients,” Desilets said.

(An anastomosis is the surgical union of two hollow organs, for example, blood vessels or part of the intestine, to ensure continuity of the passageway.)

Dr. Loring Flint, senior vice president, Medical Affairs, Baystate Medical Center, praised the medical staff’s embracing of new technology and innovative procedures such as NOTES™.

“I am proud of the entire surgical team at Baystate Medical Center who were involved in this pioneering surgery and commend Dr. Romanelli and Dr. Desilets for their collaborative and creative approach in the use of new technology which saved Mr. LaFlam’s life,” Flint said.

“We are excited to join an elite group of very few hospitals in the world who have performed a NOTES™ procedure, and are delighted to have made this important contribution to the medical community in forwarding the current research and investigation behind this revolutionary technique to benefit future patients,” he added.

Romanelli further commented on the new technology used during the procedure.

“The POWER MEDICAL INTERVENTIONS® stapler allowed us to maneuver through the esophagus and stomach, turn corners and create a large opening between the pancreas and the stomach with precisely-fired staples, all without making an incision in the patient’s abdomen. POWER MEDICAL INTERVENTIONS® platform is an essential surgical device for NOTES™, as older similar devices are too bulky and do not allow access through the body’s natural orifices,” he said.

Open surgery, which relies on the creation of an incision large enough in the patient to allow a direct view of the operating field and insertion of surgical instruments, was for years the most common form of surgery. However, over the past 30 years, surgery has undergone significant change as technological innovations such as enhanced imaging have led to improved diagnosis and as advanced instruments have facilitated both visualization and surgical access through smaller incisions. Referred to as minimally invasive surgery, the technique has replaced many surgeries once performed only by large incision.

“Now the evolution of NOTES™ is ushering in yet a new era to benefit patients by offering us an even less invasive approach to surgery involving a procedure performed through natural openings such as the mouth or anus instead of the abdominal ports used in minimally invasive surgery,” Romanelli said.

In addition, Romanelli said expanding technology and the resulting new procedures such as NOTES™ will have a significant impact on medicine in the 21st century as the medical community focuses less on specialty medicine and looks toward a more team-oriented, disease-focused approach.

“With NOTES™ we have already begun to see a blurring of distinctions between specialties as evidenced in the operating room at Baystate Medical Center where a surgeon and gastroenterologist, along with other members of the surgical team, were working side-by-side to treat Mr. LaFlam,” he added.

About Baystate Medical Center
Recently named one of the nation’s Top 100 Hospitals by Premier, Baystate Medical Center is the flagship hospital of Baystate Health in Springfield, Mass. It is the region’s only tertiary care referral medical center and Level I Trauma Center serving western Massachusetts. The 653-bed hospital is accredited by the Joint Commission on the Accreditation of Healthcare Organizations and the American Nurses Credentialing Center has named Baystate Medical Center a Magnet® hospital, recognizing its excellence in nursing services. The not-for-profit academic teaching hospital is the Western Campus of Tufts University School of Medicine and serves as a regional resource for specialty medical care and research, while providing comprehensive primary medical services to area patients. For more information on Baystate Health, visit www.baystatehealth.com

About POWER MEDICAL INTERVENTIONS®
POWER MEDICAL INTERVENTIONS® is leading the development and commercialization of Intelligent Surgical Instruments™ for bariatric, cardiothoracic, colorectal and general surgical applications. POWER MEDICAL INTERVENTIONS’ proprietary product platform, SurgASSIST, used in over 30,000 procedures globally, enables less invasive surgical techniques to benefit surgeons, patients, hospitals and healthcare networks. The Company was founded in 1999 and has corporate headquarters in Langhorne, PA, USA. To learn more about Power Medical Interventions and its products, please visit www.pmi2.com.

Tags:

Category: News and Trends, Past Articles

Comments are closed.