LANGHORNE, PA., July 16, 2009 -- Power Medical Interventions®, Inc. (OTCBB:PMII), maker of Intelligent Surgical Instruments™, announces that the company’s proprietary i60 Mid Cut device was used at Palmetto General Hospital in Miami, Florida in a novel procedure known as laparoscopic vertical gastroplasty.
This procedure is designed to combat obesity through a novel, less invasive surgical procedure which takes approximately 30 minutes to perform. The procedure was successful at reducing the size of the patient’s stomach, without removing the stomach. This new minimally invasive procedure resulted in the patient losing 17 pounds in the first week following surgery.
Jorge Sosa, M.D., chairman of the bariatric surgery department at Palmetto General Hospital, performed the procedure. He has successfully completed a total of seven laparoscopic vertical gastroplasties on morbidly obese patients, who are defined as having a Body Mass Index of 35 and over. Utilizing PMI’s proprietary Mid Cut Reload and Intelligent 60 mm Endoscopic Linear Cutter, Dr. Sosa has had success with all seven patients, each of them having experienced significant weight loss in the weeks and months following the procedure.
In addition to weight loss, some of the seven patients also experienced the complete resolution of related health conditions including hyperlipidemia and sleep apnea, as well as significant improvement in type 2 diabetes. All seven procedures were completed safely.
“The obesity epidemic that is plaguing the United States has necessitated the development of new and effective ways to assist patients in combating this condition. While a variety of surgical procedures have been utilized to combat morbid obesity during recent years, each has significant limitations that present concerns for both patients and surgeons,” said Dr. Sosa. “By leveraging the unique capabilities of PMI’s instruments, we have been able to modify a safe and reliable traditional vertical gastric stapling approach – known as the Magenstrasse and Mill procedure - and perform a vertical (sleeve) gastroplasty using minimally invasive laparoscopic techniques. Based on the impressive results that we have seen to date with regard to weight loss, as well as various co-morbidities, we believe this procedure has the potential to become a mainstay in obesity surgery.”
Enabled by PMI’s computer-assisted, power-actuated surgical instruments and unique Mid Cut Reload, the laparoscopic vertical gastroplasties performed by Dr. Sosa are minimally invasive surgical procedures designed to create a narrow sleeve in the stomach using staples without removing the stomach. As a result of the operation, a significant portion of the stomach is partially sealed off but left in place, reducing the overall size of the functioning stomach and restricting its intake potential. Using PMI’s instruments, Dr. Sosa was able to conduct the procedures laparoscopically, thus providing the patients significant benefits pertaining to pain and recovery time. Unlike some other obesity surgeries, the laparoscopic vertical gastroplasty is potentially reversible since no portion of the stomach is actually removed from the patient.
Based on Dr. Sosa’s experiences to date, laparoscopic vertical gastroplasties performed using PMI’s Mid Cut Reload have demonstrated key benefits as compared to other obesity surgeries. These include:
- Reduced incidence of “dumping syndrome,” with sugar and carbohydrate intolerance and malabsorption, as compared to gastric bypass surgery. Dumping syndrome occurs when the stomach’s undigested contents are transported or "dumped" into the small intestine too rapidly and is a common side effect of gastric bypass surgery.
- Elimination of band maintenance requirements such as adjustments and revisions, and improved weight loss as compared to the Lap-Band procedures.
- Reduced operative time and potentially fewer surgical complications as compared to sleeve gastrectomy, which requires the removal of the majority of the stomach. Avoiding removal of the stomach makes the vertical (sleeve) gastroplasty less invasive, less painful, and potentially a reversible procedure.
PMI expects that instruments the company has in late stage development will ultimately allow vertical gastroplasties to be performed using a NOTES® (Natural Orifice Translumenal Endoscopic Surgery) technique. NOTES is a new, minimally invasive surgical approach that involves passing surgical instruments through one of the body's natural orifices, such as the mouth in order to perform surgical procedures.
Operating through the body's natural orifice offers the potential for minimizing, or potentially even eliminating, external incisions and scarring, thus potentially reducing recovery time, physical discomfort, and healthcare costs when compared to traditional and laparoscopic surgeries. PMI is a recognized leader in the emerging area of NOTES-based procedures, with the company’s instruments having enabled physicians around the world to conduct first-of-their-kind surgeries.
“While our Intelligent Surgical Instruments are being used in groundbreaking surgical procedures across a wide variety of clinical indications, it is particularly gratifying to see the powerful impact our instruments are having with regard to morbid obesity surgery. Clearly, this is a segment of the healthcare industry that is in desperate need of effective therapeutic tools and we are pleased to have an opportunity to make a difference in this area,” stated Michael Whitman, president and chief executive officer of PMI. “We are eager to continue to support Dr. Sosa’s important efforts in the area of vertical gastroplasty, while also working with other surgeons across the country to perform similar procedures and deliver meaningful clinical results to their patients.”
For more information, visit www.pmi2.com
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