Approval of DyeVert Power XT (for automatic injection) means the full coronary angiography market is now available to Osprey’s DyeVert franchise
CE marking received for core European product DyeVert Power XT. (Credit: Jai79 from Pixabay)
Osprey Medical (Osprey or the Company) is pleased to announce that the Company has received CE Marking for the DyeVert Power XT 2nd generation device.
The CE Marking approval for its DyeVert Power XT device means the product can now be marketed and sold across Europe. Europe is a core market for Osprey and a significant player in the global power injector market. Our DyeVert Power XT device is expected to form a core product in the portfolio that is being commercialised by GE Healthcare.
Osprey Medical President & CEO, Mike McCormick, commented:
“We are delighted to have received CE Mark approval for our Power XT device. The CE Mark is a very significant achievement as it ultimately enables Osprey to target the full coronary angiography market as our portfolio is now compatible with both automatic and manual injection methods.
The approval was a critical building block in our European roll-out and the timing is perfect, following the strategic alliance formed with GE Healthcare in July. With the CE Mark ensuring a comprehensive product range, plus a recently published paper by renowned cardiologist, Dr Briguori; we are confident of a strong launch in Europe through the GE Healthcare sales force later this year”
The main feature of the device is its compatibility with automated power injectors, thus complementing the Company’s existing DyeVert EZ product which is compatible with manual injection. The regulatory clearance marks a critical evolution in Osprey’s DyeVert technology, as the Company now has full coverage of the coronary angiography market in Europe.
This marks another key milestone in the Company’s European strategy following the exclusive distribution agreement with GE Healthcare announced on 30 July 2020.
Clinical update
In addition to the CE Mark approval, recently and important peer reviewed manuscript was published by Dr Carlo Briguori, a key opinion leading heart physician in Italy. This study further validates the effectiveness of Osprey’s DyeVert technology at improving patient outcomes and lowering hospital cost. This important publication will form a key part of Osprey’s European sales strategy with GE Healthcare.
Some of the key findings from this paper included:
Study Design
Patients studied had heart attacks (STEMI and NSTEMI)
339 control patient’s (no-DyeVert) were compared to 112 patients who received DyeVert
Hydration (IV fluid administration) protocol was the same in both DyeVert and no-DyeVert
Observed, retrospective, propensity matched study in a single center in Naples Italy
Results
38% dye reduction in the DyeVert group compared to the no-DyeVert group
58% Acute Kidney Injury reduction in the DyeVert group compared to the no-DyeVert group
25% reduction in hospital length of stay in the DyeVert group compared to the no-DyeVert group
Source: Company Press Release