Tampa General Hospital USF Health Morsani College of Medicine Are First in Nation with New Device

Breakthrough device promises significantly improved patient recovery after colorectal surgery.

Tampa, FL (April 1, 2022) – Under the direction of site Principal Investigator Dr. Jorge Marcet, professor in the Department of Surgery and director of Colon and Rectal Surgery at the USF Health Morsani College of Medicine and colon and rectal surgeon at Tampa General Hospital, the first-ever Colovac™ procedure in the U.S. was successfully performed on the study’s first enrolled patient.

Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal resection. Up to 20 U.S. and European sites will enroll patients in the study. A groundbreaking endoluminal bypass sheath, Colovac was developed by SafeHeal™, a leading innovator in the field of digestive surgery.

Currently, patients undergoing a colorectal resection receive an ostomy to create an opening from inside the body to the outside, providing a new way for waste to leave the body into a pouch worn by the patient.

“We are excited to be the first investigative site in the U. S. to enroll patients in SafeHeal’s clinical trial of the Colovac device,” Marcet said. “Treatment of rectal cancer most often involves radiation and chemotherapy followed by surgical removal of the rectum. Because the risk of non-healing of the bowel anastomosis is high, and the consequences could be dire, the surgeon temporarily diverts the stool from the anastomosis by creating an ostomy. The patient keeps the ostomy for about 2-6 months, and the eventual reversal of the ostomy requires another operation, hospitalization, and recovery period. The aim of the SafeHeal study is to see if these patients can safely avoid an ostomy and avoid additional operations. Our initial experience with this device is positive and we are excited to be able to offer this cutting-edge technology to our patients as part of the study.”

The highest-ranked hospital in the market in U.S. News & World Report’s 2021-22 Best Hospitals, and one of the top four hospitals in Florida, Tampa General is one of the top-rated hospitals in Florida for gastroenterology and gastrointestinal surgery. The academic medical center is #26 in the country and #1 in Florida. “We are intently focused on providing the safest and most innovative care for patients with colorectal cancer, which is why we are always eager to participate in clinical trials,” Marcet noted.

An anastomosis is a surgical connection between two structures. When part of an intestine is surgically removed, the two remaining ends are sewn or stapled together (anastomosed). The procedure is known as an intestinal anastomosis.

The SAFE-2 randomized controlled IDE study will assess the safety and efficacy of the Colovac endoluminal (within the intestine) bypass sheath in adult patients who were initially scheduled to receive a diverting ostomy following colorectal surgery. Diverting ostomy, the current standard of care, is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and anastomosis, due to the high risk of anastomotic leak in this patient cohort. Anastomotic leakage, or an incomplete healing of the anastomosis, occurs in up to 20 percent of patients undergoing LAR. It is considered to be one of the most serious complications of colorectal surgery, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and potential mortality.

“Participating in a study of this caliber for a potentially groundbreaking advance in the care of colorectal surgery patients aligns with our vision to be the safest and most innovative academic health system in America,” said Dr. Abraham Schwarzberg, chief of oncology and senior vice president of network development, Tampa General.

Every year, approximately 500,000 patients worldwide undergo low anterior resection surgery, defining the broad opportunity for the Colovac device to significantly improve patient outcomes and recovery. 

“The initiation of our SAFE-2 study represents the achievement of a critical milestone in our path to eventual FDA market approval and making a positive impact in the care and quality of life of colorectal surgery patients,” said SafeHeal CEO Karl Blohm.

 

ABOUT TAMPA GENERAL HOSPITAL

Tampa General Hospital, a 1,041-bed non-profit academic medical center, is one of the largest hospitals in America and delivers world-class care as the region’s only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2021-22 Best Hospitals, and one of the top four hospitals in Florida, with five specialties ranking among the best programs in the United States. The academic medical center’s commitment to growing and developing its team members is recognized by two prestigious 2021 Forbes magazine rankings – America’s Best Employers by State, third out of 100 Florida companies and first among health care and social organizations and 13^th nationally in America’s Best Employers for Women. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal 2020 provided a net community benefit worth more than $182.5 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital’s footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health and 19 outpatient Radiology Centers. Tampa Bay residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track.  As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that uses artificial intelligence and predictive analytics to improve and better coordinate patient care at a lower cost.  For more information, go to www.tgh.org.

ABOUT USF HEALTH

USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health’s multispecialty physicians’ group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report’s national university rankings than USF. For more information, visit health.usf.edu.

ABOUT SAFEHEAL

 SafeHeal SAS, headquartered in Paris, France, and its wholly-owned U.S. subsidiary, SafeHeal Inc., is a clinical-stage medical device company which develops Colovac, a device invented by a French digestive surgeon, Dr. Charam Khosrovani, to obviate the need for a digestive ostomy in patients undergoing colorectal surgery. Colovac is a flexible bypass sheath intended to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed endoluminally and is fully reversible. The device remains in place for 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure without the need for a second surgical intervention. This enables patients to resume their normal life without the stigma and complications associated with an ostomy procedure.  Colovac is an investigational device, not currently available for sale.