Pelvic Floor Repair

AMMD Inks Research Contract

The Elevate system is an element of American Medical’s composite portfolio of products intended to treat women’s pelvic floor collapse and incontinence. Elevate is a less invasive and thorough solution for treatment of apical and anterior problems. The complete trans-vaginal methodology is intended to reduce trauma to tissue by providing precise, uncomplicated and safe apical mesh positioning in the sacrospinous ligament and obturator internus muscle through one vaginal incision. Elevate is the most popular vaginal mesh kit with over 35,000 patients treated since its launch in 2008.   

Past studies of mesh reinforcement for repairs have mainly concentrated on vaginal anatomy. The purpose of the current study is to address lower urinary tract and vaginal functions in addition to efficacy and safety. The objective, after 12 months to 24 months of follow up, is to gather evidence for the selection of the best surgical procedure for patients facing transvaginal prolapse repair. 

This study, involving a total of 214 patients, will be randomized, single blinded, and prospective, and will be conducted at half a dozen participating centers. The managing site will be the Mayo Clinic and it has selected six independent implanting sites, five of which are located in the U.S. and one in Germany.   

American Medical is slated to be acquired by specialty healthcare solutions company Endo Pharmaceuticals ( ENDP Analyst Report ), in the third quarter of 2011. Under the deal, announced in April 2011, Endo Pharmaceuticals will buy American Medical for $2.9 billion (or $30.00 per share in cash).

The consideration includes the assumption of $312 million of debt. The deal has been approved by the boards of both companies and is subject to the approval of American Medical’s shareholders, antitrust clearance and attainment of other closing conditions. The company will announce a special shareholder meeting, in due course, to secure stockholder clearance of the proposed deal. Currently, we have a Neutral rating on American Medical.

Simbionix to Expose Industry First Training Simulator for Pelvic ...

CLEVELAND–28 Apr–PRNewswire-AsiaNet/InfoQuest

Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, is pleased to announce its new training simulator for pelvic floor repair, to be exposed for the first time at the ACOG 59th Annual Clinical Meeting in Washington, DC, April 30- May 4, 2011.

The revolutionary Pelvic Mentor(TM) is an integrated hybrid system, combining a plastic mannequin with a computerized 3D virtual system. The simulator is intended to prepare gynecologists and urogynecologists for pelvic floor reconstruction with an emphasis on transvaginal mesh procedures. Pelvic organ prolapse is a common group of clinical conditions affecting millions of women around the world. Approximately 40% of women aged 40 to 80 are affected by pelvic organ prolapse, a condition in which weak pelvic floor muscles cause the pelvic organs to fall out of place. Pelvic organ prolapse can cause uncomfortable pelvic pressure, limiting the woman’s physical activity and sexual intimacy.

Pelvic floor reconstructive surgeries require surgical expertise, knowledge of both abdominal and vaginal physiology anatomy and experience with the procedure itself. This unique system was designed to allow trainees to obtain detailed knowledge of pelvic anatomy and to acquire comprehensive skills in pelvic reconstructive surgery for pelvic organ prolapse and urinary incontinence to enhance patient safety. The Pelvic Mentor’s innovative concept utilizes numerous external sensors that are either embedded inside a medical device or worn on the trainee’s finger. These sensors, combined with the mannequin and the 3D picture, enable the trainee to obtain a real-time indication of the finger palpation or device manipulation on virtual anatomical structures.

The Pelvic Mentor is a strong didactic tool, enabling the trainee to receive real-time feedback while recognizing the relevant anatomical sections and / or manipulating the relevant medical device within the pelvis cavity. The unique combination of the model’s anatomical structure, finger sensation and virtual model provide the most effective training tool to date.

“Utilizing cutting edge technology, we are introducing our first system to address the training needs for non MIS procedures, going beyond what is currently available in the industry”, says Ran Bronstein, Simbionix President. “The Pelvic Mentor hybrid simulator takes the training experience one step closer to reality by combining true to life tactile sensation. The new hardware tracks the trainee’s movements more accurately, allowing the instructor to better view the trainee’s movements, and providing the trainee with a more complete training experience. The Simbionix Pelvic Mentor is yet another example of the company’s commitment to provide comprehensive educational solutions for OB/GYN surgeons, joining the solutions provided on the LAP Mentor and the VirtaMed HystSim.

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