BLOOMINGTON, Ind.--(BUSINESS WIRE)--The FDA has granted Cook Medical approval to market Hemospray™ in the United States. An endoscopic hemostat, Hemospray achieves hemostasis with a proprietary inorganic powder. Bleeding in the gastrointestinal tract is a leading cause of morbidity and is associated with an estimated 20,000 deaths per year in the United States alone.1 Since 2011, Cook Medical’s Hemospray has been used to treat bleeding in the GI tract, with thousands of patients treated throughout Europe, Canada and other countries around the globe.
“We are extremely pleased to receive this approval to market from FDA,” said Barry Slowey, president of Cook Winston-Salem and vice president of Cook Medical’s Endoscopy specialty. “We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States.”
Hemospray will soon be available to clinicians across the U.S. for the treatment of non-variceal GI bleeds. This product is a single-use device that delivers hemostatic powder through the channel of an endoscope toward the source of a bleed. When the powder comes in contact with blood, it absorbs water and forms a gel, which acts cohesively and adhesively to create a stable mechanical barrier that covers the bleeding site. Hemospray is a nonthermal, nontraumatic treatment modality for achieving hemostasis.
“Hemospray gives clinicians another tool for the care of their patients,” said DJ Sirota, vice president of Cook Medical’s MedSurg division. “Patients have been our number one priority for over 50 years and we’ve worked hard to bring this innovation to the field of gastroenterology across the U.S.“
Numerous reports in the clinical literature have demonstrated the clinical utility of Hemospray when used alone or with other methods.2 In a summary of 19 studies of Hemospray comprising treatment of 234 patients, the combined rate of successful hemostasis was 88.5 percent. Rebleeding occurred within 72 hours in 16.2% after successful initial hemostasis with Hemospray.
Current endoscopic hemostasis treatment options can be challenging. Thermal, mechanical or contact devices can carry a risk of further tissue damage and require precise placement of the device directly onto the bleeding vessel.3 Hemospray represents a different approach to treat GI bleeds by helping to achieve hemostasis without the precision or direct visualization required of other current treatments.3 This makes Hemospray a treatment option for bleeding from damaged tissue where the bleeding source cannot be easily identified.
About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world's healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at cookmedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn.
1 El-Tawil A., Trends on gastrointestinal bleeding and mortality: Where are we standing?, World J Gastroenterol, 2012. 18: 1154-58
2 Changela K, Papfragkakis H, Ofori E, et al. Hemostatic powder spray: a new method for managing gastrointestinal bleeding. Therapeutic Advances in Gastroenterology. 2015 May; 8(3):125-35.
3 Adverse events of upper GI endoscopy. Gastrointestinal Endoscopy, 2012. Vol. 76, No. 4: 707-708