A Medical Device Daily

Stentys (Paris) has received the CE mark for its self-expanding and disconnectable stent to treat acute coronary syndrome (ACS).

The self-expanding feature of the Stentys platform is designed to ensure optimal apposition of a stent in the critical initial hours and days after an acute myocardial infarction (AMI) procedure, by being continuously applied to the vessel's internal surface even during thrombus and vessel spasm relief-thereby avoiding malapposition, a significant concern to cardiologists.

“For European regulatory approval we have demonstrated how the Stentys stent perfectly conforms to a variable vessel anatomy after AMI stenting,“ said Gonzague Issenmann, CEO and co-founder of Stentys. “Our strategy is to expand clinical evaluation with our APPOSITION II clinical study. This is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in AMI patients, using extremely high-resolution OCT (optical coherence tomography) imaging to validate endpoints.“

Gentronix signs assay deal with GlaxoSmithKline

Gentronix (Manchester, UK) has entered into a three-year agreement with GlaxoSmithKline (GSK; London) to provide GreenScreen HC and BlueScreen HC genotoxicity assays for use by GSK in genotoxicity screening.

This agreement extends the existing relationship between Gentronix and GSK in respect of GreenScreen HC, to include the use by GSK of BlueScreen HC in 384 well format, the latest Gentronix human cell reporter-based assay for compound profiling.

GreenScreen HC was the first human cell-based assay technology that combined high sensitivity for detecting genotoxic chemicals with high specificity for reducing false-positive results. This assay gives rapid results, provides additional data for safety profiling and consumes very low quantities of compound.

BlueScreen HC is the new Luciferase based assay that combines all of the attributes of GreenScreen HC with the ability to be run in 384 well micro-titre plate format. This assay provides a viable route to early detection of genotoxicity, which is known to be associated with compound attrition.

The reporter-based assays have been demonstrated to detect known classes of genotoxic agent, and utilize Green Fluorescent Protein or Gaussia Luciferase in order to detect GADD45a up-regulation, which is a key indicator of DNA damage.

Diamedix in distribution deal with Fumouze

Ivax Diagnostics (Miami), an in vitro diagnostics company, said that Diamedix (Rome) has signed a distribution agreement with Fumouze Diagnostics (Paris), a division of Sofibel (Paris), pursuant to which Fumouze Diagnostics will be the exclusive third party distributor of Diamedix and Delta Biologicals' (Tucson, Arizona) suite of diagnostic tests in France. Diamedix is a U.S. subsidiary of Ivax Diagnostics and Delta Biologicals is Ivax Diagnostics' subsidiary located in Italy. The initial term of the distribution agreement is three years.

To support the sales efforts in France under this distribution agreement, Fumouze Diagnostics has agreed to hire a sales representative to sell Diamedix and Delta Biologicals' products in collaboration with Fumouze Diagnostics' existing direct sales force. Diamedix and Delta Biologicals have a combined suite of products that includes more than 200 diagnostics tests in the areas of infectious disease, autoimmune disease and allergies. Delta Biologicals also manufactures a line of instruments for use in clinical and hospital laboratories.