Apollo Endosurgery Announces 510(k) Clearance for Its Flexible Endoscopic Suturing System

Friday, October 3, 2008 General News
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AUSTIN, Texas, Oct. 2 Apollo Endosurgery Inc. announcedtoday that the FDA has cleared a 510(k) application to market itsOverStitch(TM) endoscopic suture system. This allowance opens the way for UScommercial release of the product, which is anticipated for late 2008.

The OverStitch system is a single-use device that fits onto standardflexible endoscopes and enables physicians to place full thickness running orinterrupted sutures into targeted tissues.

"Adapting suturing to a standard flexible endoscope platform is a majoraccomplishment," explained Dr. Santiago Horgan, Director of Minimally InvasiveSurgery and the Center for the Future of Surgery at the University ofCalifornia San Diego. "The OverStitch system will enhance the ability toperform full thickness tissue apposition and anastomosis reliably by lettingus mimic how we would suture laparoscopically."

"The capability to suture endoscopically makes the device a valuable toolfor a variety of endolumenal GI procedures," said Dr. Jeffrey Marks, AssociateProfessor in the Department of Surgery at University Hospitals Case MedicalCenter. "The use of a tool like the OverStitch system will enable the advancedendoscopist to perform more aggressive procedures such as EMR and fullthickness resection."

The OverStitch endoscopic suture system is a fully disposable suturingsystem that allows a physician to use a standard flexible endoscope to placesutures. The device quickly mounts to common therapeutic endoscopes and isdesigned to safely navigate through delicate areas of the anatomy. Once at thesurgical site, custom needle-suture sets -- available with standard absorbableand non-absorbable materials up to 2-0 in thickness -- can be loaded andreloaded without removing the device or the endoscope. The physician can thenplace either an interrupted or running stitch, which can be secured with anincluded cinching device or by using the device itself to tie a surgical knot.

"The 510(k) clearance of the OverStitch endoscopic suture system is asignificant step towards making the benefits of endolumenal surgery arealistic therapeutic option in hospitals and clinics across the country,"said Dennis McWilliams, CEO of Apollo Endosurgery, Inc. "This is a majormilestone for the company and is a testament to Apollo Endosurgery's continuedcommitment to be an innovative leader in the field of advanced minimallyinvasive surgery."

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. develops and markets medical devices forminimally invasive surgical procedures conducted through natural orifices.These minimally invasive procedures are at the convergence of flexibleendoscopy and general surgery, and include procedures inside thegastrointestinal tract (endolumenal surgery) as well as procedures that crossthe lumen to the peritoneal cavity (known as translumenal surgery, or NOTES).Using a new class of Apollo's proprietary flexible access devices and surgicaltools, surgeons and gastroenterologists will be able to perform scarlessinterventions for the treatment of early stage cancers, obesity, and generalsurgical procedures in the peritoneal cavity. In addition to avoiding thescars caused by abdominal incisions, these procedures are expected to resultin less pain, require less sedation, and lead to faster recovery times.Apollo Endosurgery was cofounded with the Apollo Group, a unique collaborationof physicians from the Mayo Clinic, Johns Hopkins University, MedicalUniversity of South Carolina, the University of Texas Medical Branch, and theChinese University of Hong Kong. The company is funded by PTV Sciences andH.I.G Ventures.Contact: Lee Putman Vice President Sales and Marketing Apollo Endosurgery, Inc. 512.328.9990 (o) 513.703.3230 (m)

SOURCE Apollo Endosurgery Inc.

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