The American Society of General Surgeons has endorsed the confocal laser endomicroscopy platform Cellvizio for managing patients with gastroesophageal reflux disease and Barrett’s esophagus, according to a press release from the manufacturer.
“With esophageal cancer rates having increased by 600% since the introduction of powerful acid reducing medications, the accurate detection and determination of extent of Barrett’s is greatly enhanced by Cellvizio [Mauna Kea Technologies],” F. Paul (Tripp) Buckley III, MD, surgical director of the Heartburn & Acid Reflux Center at Baylor Scott & White Health in Central Texas, and member of the board of trustees of the ASGS, said in the press release. “We believe that physicians and surgeons who are fighting every day to relieve patients from GERD and to prevent them from later developing Barrett’s esophagus ... need and deserve to have access to Cellvizio in order to obtain a comprehensive assessment of the extent of disease and to make real-time therapeutic decisions.”
The ASGS position statement, which will be available on the society’s website, estimates that GERD patients have a 10% to 15% risk for developing Barrett’s esophagus, which is associated with a 30% to 50% increased risk for cancer, according to the press release.
Other sources cited in the press release estimate that GERD affects 10% of Americans every day, 18% every week and almost 44% every month; that 8.9 million U.S. hospital visits were attributed to GERD in 2012; and that around 6.9 million upper endoscopies were performed in the same year. Moreover, according to the manufacturer’s internal estimates, 5 million upper endoscopies per year could benefit from Cellvizio procedures, which are currently reimbursed with CPT codes 43206 and 43252.
“We are extremely gratified by the ASGS’s position statement on confocal laser endomicroscopy. Combined with the American Gastroenterological Association’s 2015 white paper which deemed the use of confocal laser endomicroscopy to be appropriate for trained physicians as an alternative to random biopsies, we now have two important clinical endorsements for the use of Cellvizio in the treatment of GERD and Barrett’s esophagus,” Sacha Loiseau, PhD, founder and CEO of Mauna Kea Technologies, said in the press release. “We are confident this additional position statement will be a catalyst for accelerated utilization of Cellvizio in U.S. anti-reflux centers and hospitals, an application which has already proven to be very dynamic.”
A Cellvizio system was recently placed at the Florida Hospital Center for Interventional Endoscopy (CIE), the highest volume interventional endoscopy unit in the U.S., according to a separate press release from the manufacturer.
The center’s international recognition represents “a significant opportunity to drive increased awareness” of Cellvizio in clinical and research communities. Last year, the CIE performed more than 6,200 complex endoscopic procedures, including more than 2,700 endoscopic ultrasound (EUS) procedures, 831 of which were fine needle aspiration procedures that can often be improved with Cellvizio technology, according to the press release.
“The Florida Hospital Center for Interventional Endoscopy (CIE) has adopted Cellvizio so that patients can be evaluated using cutting-edge diagnostic technology,” Shyam Varadarajulu, MD, medical director at CIE, said in the press release. “Cellvizio will help expand CIE’s advanced imaging portfolio and facilitate better management of patients. A major mission of CIE is to conduct high quality clinical trials and we hope that Cellvizio will be instrumental in providing answers to diagnostic dilemma in the evaluation of pancreatic cysts and indeterminate biliary strictures.”
The CIE will feature the Cellvizio system at its 4th annual Orlando Live EUS symposium September 7-9, according to the press release.
Loiseau is employed by Mauna Kea Technologies. Healio Gastroenterology was unable to confirm Buckley’s and Varadarajulu’s relevant financial disclosures.