Minos Medical Inc. and Vision Sciences Inc. Conduct Pioneering NOTES Cadaver Lab

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Natural orifice surgery, the next frontier in surgery is already here. Minos Medical Inc and Vision Sciences Inc investigate exciting new NOTES procedures.

Access into the abdominal cavity is needed to perform surgical procedures for diagnostic and therapeutic purposes. For centuries, abdominal access was achieved using a scalpel to create traditional surgical incisions. During the late 1980's the laparoscopic approach, also called "keyhole surgery," changed the face of surgery. It provided entry into the abdomen through multiple trocars, small hollow tubes inserted into the abdominal cavity to facilitate the passage of a laparoscope (a rigid tube containing a video camera and combined light source to provide vision) as well as biopsy and operating instruments. Prior to that, laparoscopy was primarily performed to visualize the underlying abdominal structures and organs, or to remove small amounts of tissue for biopsy. Today, with the advent of improved surgical instrumentation, laparoscopic surgery has become a standard of care for many surgical procedures.

The recognized advantages of laparoscopic surgeries such as removal of gallbladders are decreased incisional pain, reduced trauma, less post operative recovery time, quicker return to normal activity and, of course, improved cosmetics for the patient. These benefits have launched a worldwide acceptance of this type of minimally invasive surgery.

While beneficial to most patients, even laparoscopic procedures may still present with potential post-surgical drawbacks such as trocar incisional hernias, tissue adhesion, wound infection, improved but still poor cosmesis, and pain. With laparoscopy the main organ that doctors have to traverse is the largest organ of the body… the skin.

Currently, teams of doctors around the world are evaluating the access to the abdominal cavity by inserting long endoscopes, (flexible tubes with a camera and light source) through natural body openings such as the mouth, rectum or vagina. They avoid cutting the skin, and proceed through a different and much smaller organ such as the stomach, colon, bladder or uterus as a means of performing different types of "Natural Orifice Surgery."

Just as before, when laparoscopy was expanded to enable more complex procedures, doctors are finding innovative ways to access via the mouth, rectum or vagina and traverse through the stomach and other organs to reach inside the abdomen. Once done, the procedure becomes known as NOTES (Natural Orifice Translumenal Endoscopic Surgery). This method of surgery eliminates all skin incisions, and much of the post operative pain. Once inside the abdomen, the doctors can then navigate using advanced instrumentation to perform more complex procedures.

So far, much of the NOTES work has been only experimentation and still needs to be validated by the medical community. Recently, several doctors around the world, including the US and Europe, have started to perform operations in human patients. Procedures have included removal of the appendix or gallbladder via the stomach and vaginal canal.

Key to this advanced surgery will be the use of flexible endoscopes that have small channels down which instruments are passed to perform the surgery. These small channels, approximately 2mm to 4mm in diameter, prove notoriously difficult to clean and then sterilize. Further, most flexible endoscopes required for this type of surgery cannot be sterilized because the process would damage them. Thus, sterile instrument access to the operative site is a significant challenge for the long-term prospects of NOTES.

Vision Sciences, Inc. (VSI) develops a unique range of flexible endoscopes that simply slide into a proprietary sterile, disposable sheath, ensuring only a sterile flexible insertion tube ever enters the patient. With the need for sterility in NOTES procedures VSI is uniquely positioned to penetrate this space in a convincing manner. Along with the high quality image which doctors will need to accurately perform NOTES procedures, VSI's disposable Endosheath® technology also houses the operating channel or channels, assuring a sterile pathway for each endoscopic procedure. Moreover, the Endosheath® technology allows for customization of the sheath configuration, the number of integrated channels, their size and the diameter of the sheath to accommodate an array of various sizes and shapes of laparoscopic tools which many surgeons are already familiar with.

Several other companies are already developing other exciting technologies to make natural orifice surgery easier. Minos Medical, Inc (Minimally Invasive Natural Orifice Systems) of Irvine, California is one of the pioneering companies developing both new therapies and surgical devices. VSI is a significant shareholder of Minos, and the two companies are collaborating in the field of natural orifice and NOTES to accelerate development.

"It's an exciting time for surgery," says Brad Sharp, CEO of Minos Medical. "We are pleased to be developing such novel therapies and devices. This is something that could really change the way surgery is done."

Minos is developing NOTES systems for treating the appendix, the gallbladder, and for entering the abdomen to perform diagnostic & therapeutic procedures. Also under development are new therapies for diverticulitis and vaginal hysterectomy. Minos plans to start first human trials with their Appendoectomy™ system by the end of 2007.

"Minos Medical is a major leader in this space," says Mr. Ron Hadani, CEO of Vision Sciences. "Their progress in this area is the major reason we have invested in this progressive company."

Recently, Minos and VSI jointly conducted successful cadaveric studies to evaluate performance of their NOTES technologies at a major academic institution in New York City. Performing the procedures were Dr. Mark Slack, Head of department of Urogynaecology and Pelvic Reconstructive Surgery, University of Cambridge Teaching Hospitals Trust, Cambridge, UK and Stephan Grochmal, MD, Associate Clinical Professor, Division of Operative Gynecology, Endoscopy and Laser Surgery, Howard University College of Medicine, Washington, DC.

Both doctors agreed with Mr. Carlos Babini, Executive Vice President of Vision Sciences, Inc., who had an extensive role in ushering in the laparoscopic surgery era during the late 80's when he stated, "The last time I saw this much promise was during the formative laparoscopic years."

Doctors may soon have another set of innovative tools for their practice, and hospitals may see a reduction in total healthcare spending, however the ultimate winner with this type of surgery will clearly be the patient.

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