Nov 25, 2013 (ACCESSWIRE via COMTEX) -- ** FDA has Invited the Company to Meet the Review Team **
Seattle, Washington, November 25, 2013 - Ventripoint Diagnostics Ltd. CA:VPT +14.29% is pleased to announce that after careful review of the information received from the U.S. Food and Drug Administration (FDA) regarding market clearance of the Ventripoint Medical System ("VMS(TM)") for use in Pulmonary Arterial Hypertension (PAH), the Company has developed a strategy for addressing the concerns raised by the Agency.
The results of the clinical trial demonstrated that the calculated parameters between right ventricular volumes computed from echocardiograms by VMS and MRI images computed with Simpson's rule were within the pre-specified 10% range for each of the mean difference and 95% confidence interval (4.8+/-1.4% for EDV, 1.8+/-1.5% for ESV, and 2.0+/-0.7% for EF). Nevertheless, the Agency had some concerns about the routine use of the VMS in this patient population.
In advance of filing a formal appeal, Ventripoint has received an invitation to meet with the review team to gain an understanding of the reasoning behind the current decision. This is an important first step in the appeals process and will form the basis of discussions throughout the appeal.
"It is important for us to fully engage the FDA through the available engagement and appeal processes", stated Jim Bodtke, Vice-President of Clinical Affairs. "We currently have other submissions for requesting regulatory approval of various applications for the VMS and we need to better understand the current criteria for acceptance before initiating these submissions."
In addition to the above, Ventripoint has reached distribution agreements for France, Germany, Austria and Switzerland for the VMS with further expansion planned. "We look forward to the upcoming EuroEcho meeting December 11-14, 2013 in Istanbul to meet with the cardiology community and distributors for Western and Eastern Europe as well as the Middle East," said Jerry Gatewood, Vice-President of Global Sales and Marketing. "Many areas in the world have expressed interest in offering VMS in their respective regions for a more comprehensive evaluation of the right ventricle."
The VMS is approved for clinical use for multiple heart conditions in Canada and Europe and continues to be available for investigational use only in the United States.
