PuraShield: the new medical device for ENT has been launched in Spain
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3-D Matrix
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Operating successfully in the Spanish market with its existing flagship products, PuraStat for gastroenterology and PuraBond for cardiac surgery, 3-D Matrix is thrilled to announce the expansion of its product portfolio with the introduction of PuraShield, a cutting-edge haemostatic agent, specifically designed for use in Ear, Nose, and Throat (ENT) surgical procedures.
PuraShield is licensed as a medical device for achieving haemostasis in several ENT procedures. Formulated from self-assembling peptides (SAPs), founded at the Massachusetts Institute of Technology (MIT), PuraShield is a ready-to-use, slightly viscous hydrogel available in the form of a prefilled syringe. When in contact with bodily fluids, such as blood, it is able to achieve haemostasis by creating a three-dimensional barrier similar to the human extracellular matrix, which stops bleeding effectively (1).
PuraShield’s distinctive viscosity and transparency make it particularly suitable for application in narrow spaces, enabling surgeons a clear view to continue procedures. Additionally, its key features offer tangible benefits for both patients and hospitals by minimising patient discomfort, and potentially, the formation of adhesions, often associated with using traditional packing methods. Overall this may lead to shorter hospital stays and a reduction in the total cost of care (2).
In the ENT field, PuraShield is indicated for a range of surgical procedures, including but not limited to adult tonsillectomy, FESS (Functional Endoscopic Sinus Surgery) and TORS (Trans-oral robotic surgery) for sinus, oral and neck surgeries, as well as rhinoplasty for plastic surgery.
Set to be available from April 2024 in the Spanish market in 3 mL and 5 mL volumes, PuraShield’s launch marks the beginning of a fresh new partnership with the local distributor Prim, through which 3-D Matrix will ensure a solid distribution network for the hydrogel solution throughout the Spanish market.
PuraShield’s launch also marks a significant milestone for the Company which keeps expanding its product portfolio and pipeline in different medical specialities, continuing to leverage the valuable collaboration with its distributor partners across the World.
Please note availability of this product may vary from one Country or Region to another, due to specific local regulatory approval or clearance requirements for sales.
Click here to read more about PuraShield.
(1) PuraShield is indicated for haemostasis in the following situations encountered during surgery when haemostasis by ligation or standard means is insufficient or impractical (*):
- Oozing from vascular anastomoses to native or artificial vessels, on the surface of blood vessels and surrounding tissues
- Bleeding from small blood vessels and oozing from capillaries of the parenchyma and surrounding tissues of solid organs
* PuraShield IFU 015-Rev 2