This week, we are talking about Hemospray®, a device marketed by Cook Medical that has been developed for hemostasis of Non-Variceal gastrointestinal Bleeding (NVGIB). Quite the mouthful there, right? Let’s talk about what NVGIB is in order to better understand how the device works.
Non-Variceal Gastrointestinal Bleeding (NVGIB) is bleeding that develops in the upper gastrointestinal tract, stomach, or the proximal duodenum. The most common cause of the bleeding is a peptic ulcer caused by the gut bacteria Helicobacter pylori (H. pylori) infection. This type of infection is often associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin, and can be uncomfortable to live with.
H. pylori infections are most commonly treated with antibiotics, however, the more serious resulting NVGIB continues to be a medical emergency with a mortality rate of approximately 1–5% (Lanas et al., 2018). Recent advances in the prevention and management of NVGIB has resulted in decreased incidence (~67 per 100,000 individuals). However, treatment for NVGIB has not yet been perfected, with options such as endoscopic interventions and pump inhibitors being the current methods of treatment. Here is where Hemospray comes in.
Hemospray® is a single use device which achieves hemostasis using a proprietary mineral blend powder. This inorganic powder is metabolically inert and is not absorbed by the body; instead passing through the lower GI tract within 72 hours after application. According to the manufacturer, Hemospray® has advantages over traditional therapies as it is a non-thermal, non-traumatic, non-contact treatment. The device uses a catheter that is inserted through an endoscope to the site of the bleed. The catheter delivers the powder using a carbon dioxide-powered delivery system. When the powder contacts an active bleeding site, it absorbs water and forms a mechanical barrier by acting both cohesively and adhesively (as shown in step three and four of the image below). This barrier blocks further bleeding from occurring, and seals off the hemorrhage or bleeding site.
FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, and supplemented this data with real world evidence from medical literature reports that included an additional 522 patients. The Hemospray device stopped GI bleeding in 95 percent of patients within five minutes of device usage. Re-bleeding was observed in only 20 percent of these patients between 72 hours and 30 days following device application. Hemospray is contraindicated for patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation .
An ease of use comparison study carried out on 79 patients showed that Hemospray® was comparable to or easier than other hemostasis treatment modalities. Hemostasis was achieved in less than 10 minutes in over 77% of cases and thought to save time in 59% of cases (Morris et al.,2014).
FDA reviewed the device under their de novo pathway and concluded that Hemospray® be classified as a Class II, moderate risk device. In addition to general controls that are applicable to a Class II device, these types of devices are also subject to the following special controls:
1. Biocompatibility testing of the patient-contacting components of the device
2. Sterility and pyrogenicity of patient-contacting components of the device the device
3. Shelf life
4. In vivo performance testing
5. Non-clinical performance testing
We’re excited to see new device-based treatment options for diseases like NVGIB! We’re also excited to see FDA accept real world evidence in support of premarket submissions. There is a big effort at the agency on reducing burden, improving patient safety, and supporting new technologies like the Hemospray® device. Using real world evidence to bring products like this to market is one of the ways FDA continues its mission!
1. Lanas A, Dumonceau JM, Hunt RH, Fujishiro M, Scheiman JM, Gralnek IM, Campbell HE, Rostom A, Villanueva C, Sung JJY. Nature Reviews Disease Primers. volume 4, Article number: 18020 (2018)
2. Morris AJ, Smith LA, Stanley A, et al. Hemospray for non-variceal upper gastrointestinal bleeding: Results of the Seal Dataset (survey to evaluate the application of Hemospray in the luminal tract). Journal of Clinical Gastroenterology. 2014 Nov; 48(10): E89-92.