Endoscopic Solutions
Whether it is a routine polypectomy or a more complex ESD procedure, the management of intraprocedural bleeding, and particularly delayed bleeding, remain a significant challenge for endoscopists. If bleeding is not managed effectively during the procedure it can lead complications such as delayed bleeding.Based on self-assembling peptide technology, 3-D Matrix has obtained CE mark approval for the transparent haemostatic hydrogel, PuraStat®, which has several features that make it unique.
Challenges During Endoscopic Procedures
Bleeding is the most frequent complication during endoscopic procedures1.
For intra-procedural bleeds, some solutions such as clips and cauterisation are not suitable for the location of the bleeding, particularly in small difficult to reach areas. Maintaining clear visibility during haemostasis is important, especially when working within a tight enclosed space.
There is also a risk of delayed bleeding following endoscopic procedures, especially after endoscopic submucosal dissection (ESD). If untreated, delayed bleeding can lead to serious conditions such as haemorrhagic shock1.
The Benefits of PuraStat®
PuraStat® is an easy-to-use, transparent hydrogel that enables precise work in a narrow space without any compromising the view during endoscopic procedures. It is inert, non-adhesive and easily deliverable through an endoscopic applicator. PuraStat can also add value when used in combination with clips and cauterization.
PuraStat has also been proven to reduce the rate of delayed bleeding following colonic ESD by 50%2.
For application within gastro-enterology, PuraStat is indicated3 for:
- Achieving haemostasis in bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures [when haemostasis by ligation or standard means is insufficient or impractical]
- Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon.
“In addition to its efficacy in stopping bleeding, we found more advantageous properties of [PuraStat]*, especially during endoscopic surgery. First, [PuraStat]* is a clear material. It does not block the field of view, which is particularly important during endoscopic surgery. Second, [PuraStat]* is applied as a solution and only gelates when in contact with body fluids, making it easy to apply.” 4
*In this study the name PuraMatrix is erroneously used instead of PuraStat
“PuraStat is [a] very helpful new tool in haemostasis that allows successful application also in such special bleeding sites as the duodenal papilla, where clipping is very difficult/dangerous because of the orifice of pancreatic and bile duct.
PuraStat is very easy to use.”
Professor Jens Tischendorf, M.D.
Department of Internal Medicine und Gastroenterology, Rhein-Maas Hospital, Würselen, Germany
Important Note: The IFU-002 rev2.2 is currently approved only in Europe. The current IFU outside of Europe depends on the registration status. The approved indication can differ in your country, please contact 3-D Matrix if you need any additional information on device indication.
