This website is for registered healthcare professional who have a valid certification in your possession. This website is not intended for French healthcare professionals.

User Login

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.

1
Kim et al. 2019. ‘Management of Complications of Colorectal Submucosal Dissection’ Clinical Endoscopy. 52. 114-119. DOI:10.5946/ce.2019.063
2
Subramaniam S., Kandiah K., Fujimoto A., Yahagi N., Toshio Uraoka T., Bhandari P. 2017. ‘Minimising the risk of delayed bleeding in colonic endoscopic submucosal dissection: Is there a role for a novel haemostatic peptide?’ United European Gastroenterology Journal 2017; 5 (Supplement 1)
3
PuraStat IFU-002 Rev 2.2. Last revision 04/2019
4
Kondo Y, Nishizaki M, Nagasaka T, and Fujiwara T. 2012. Puramatrix* is a new and useful hemostat in endoscopic surgery. Surg Endosc. 26:S53–S140. P325–Technology S126.DOI 10.1007/s00464-012-2199-2

If you are interested in learning more and getting connected to your local representative, please contact us.

3-D Matrix Solutions

Endoscopic Solutions

PuraStat® fits requirements for a hemostat in endoscopy and enables precise work in a narrow space. It is inert, transparent, deliverable through endoscopic applicator, non-adhesive and not clogging.
Current Page

Laboratory Solutions

PuraMatrix® is the first commercial synthetic extracellular matrix (ECM) scaffold based upon self-assembling peptides, enabling cells to be cultured in carefully controlled microenvironments for life science research, pharmaceutical drug discovery and bioproduction.

Surgical Solutions

The ability to stop and control bleeding is critically important to all surgical procedures and to the practice of medicine in general. Based on the self-assembling peptide platform technology, 3-D Matrix has obtained CE mark approval for the surgical haemostatic agent PuraStat®.

Therapy Innovation

The ability of PuraStat® to be applied through the dedicated nozzle and also through the specially designed catheters is ideal for minimally invasive surgery. Application of PuraStat® through small incisions to internal body tissues facilitates haemostasis, at the affected area while reducing the risks associated with open surgeries.