The Seal One device from Perouse Medical (Ivry Le Temple, France) allows for precise adjustment and control of compression levels of the radial artery. ELASTO Sweden developed two grades of Mediprene thermoplastic elastomer for the wrist strap and transparent compression pad.
The Seal One radial compression device is used in interventional imaging, indications for coronarography and angioplasty. It targets the radial artery and has been designed to limit the risk of radial artery occlusion while ensuring no compression of the ulnar artery. It is a complete solution, with no further accessories required. It allows for controlled and optimised usage time.
It features a compression / decompression knob with scale, a decompression safety button and a time indicator for display of positioning time. The special two-step decompression design also helps to limit the risk of unintended decompression, simplifies handling for the health-care practitioner and allows for easier monitoring of decompression protocol.
The crystal clear transparency of the Mediprene TPE grade used in the compression pad gives enhanced visibility of the puncture site, allowing for better visible control. A grade of Mediprene TPE was also developed to give the soft touch, non-irritating and flexible properties required for the wrist strap.
Mediprene TPEs have been engineered to address the demands of the medical device industry. Representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI. The materials are latex free, which reduces the risk of allergic reactions; Mediprene TPEs have been classified as non-sensitizers. Mediprene TPEs are sterilizable with gamma, EtO and steam.
Mediprene TPEs are available in a range of hardnesses; from a gel-soft zero shore A material through to 62 Shore D. For overmoulding applications, Mediprene offers grades with excellent adhesion to a variety of substrates including PP, PE, ABS, PC, PETG and SMMA. The Mediprene range also includes oil free compounds which were developed to address demands for transparent medical TPE grades with a minimum of potential extractables and leaching. Mediprene TPEs are manufactured under rigorous controls with regard to traceability, consistency and change control at Elasto Sweden’s ISO 13485 accredited facilities.
ELASTO Sweden will be showcasing the latest developments in Mediprene TPEs at CompaMed (20 – 22 November, Dusseldorf 8A : R14)