Nearly two years have passed since the International think tank named the Apollo Group founded Apollo Endosurgery (Austin, Texas). In that time, the company has had a great deal of success, including the development of a gastric peritoneal access device that employs a balloon on either side of the gastric wall to prevent infection by sealing off any potential oral contaminants from entering the peritoneum.
Most recently the up-and-coming company reported receiving FDA approval to market its OverStitch endoscopic suture system, a device that's described as a single-use device that fits onto standard flexible endoscopes.
"Adapting suturing to a standard flexible endoscope platform is a major accomplishment," said Santiago Horgan, MD, director of minimally invasive surgery and the Center for the Future of Surgery at the University of California, San Diego. "The OverStitch system will enhance the ability to perform full-thickness tissue apposition and anastomosis reliably by letting us mimic how we would suture laparoscopically."
OverStitch is expected to be available on the market later this year, the Texas-based start-up said.
Here how the device works:
OverStitch quickly mounts to common therapeutic endoscopes and is designed to safely navigate through delicate areas of the anatomy. Once at the surgical site, custom needle/suture sets — available with standard absorbable and non-absorbable materials up to 2-0 in thickness — can be loaded and reloaded without removing the device or the endoscope. The physician then can place either an interrupted or running stitch, which can be secured with an included cinching device or by using the device itself to tie a surgical knot.
"The 510(k) clearance of the OverStitch endoscopic suture system is a significant step toward making the benefits of endolumenal surgery a realistic therapeutic option in hospitals and clinics across the country," said Dennis McWilliams, CEO of Apollo Endosurgery. "This is a major milestone for the company and is a testament to Apollo Endosurgery's continued commitment to be an innovative leader in the field of advanced minimally invasive surgery."
Apollo touts that its device will be able to perform "scarless" interventions for the treatment of general surgical procedures in the peritoneal cavity. In addition to avoiding the scars caused by abdominal incisions, the company these procedures are expected to result in less pain, require less sedation, and lead to faster recovery times.
"The capability to suture endoscopically makes the device a valuable tool for a variety of endolumenal GI procedures," said Jeffrey Marks, MD, associate professor in the department of surgery at University Hospitals Case Medical Center (Cleveland). "The use of a tool like the OverStitch system will enable the advanced endoscopist to perform more aggressive procedures such as EMR and full thickness resection."
The company faces staunch competition from Pare Surgical (Englewood, Colorado), which offers its own endoscopic suturing system – Quick-Stitch. That device offers a 5 mm delivery system and pre-tied Roeder knot. The company touts a procedure that reduces hospital stay and has significantly less post-op pain with a quicker return to normal activities. The device has been on the market for 10 years.
Pare's device was developed around the same time the Apollo group think tank — with members from such institutions as the Mayo Clinic (Rochester, Minnesota), Johns Hopkins University (Baltimore), Medical University of South Carolina (Charleston), the University of Texas Medical Branch (Galveston) and the Chinese University of Hong Kong — formed.
According to the Apollo's website, the company formed because it was "disappointed" with the pace of innovation in therapeutic flexible endoscopy.
The mission was to focus on a plan to progress therapeutic flexible endoscopy, specifically the use of long flexible instruments deployed through a natural orifice to diagnose and potentially treat gastrointestinal disorders. The group conducted its first preclinical NOTES studies in 2001 and published its first NOTES literature in 2002.
Since forming, the Apollo Group has had efforts that have resulted in 17 issued patents, 35 applications in review, and 130 disclosures. The company has secured $11.5 million in Series A financing from PTV Sciences (Austin), HIG Ventures (Miami) and individual investors.