VentriPoint Diagnostics Ltd announces the Children's Hospital of Colorado, The Children's Hospital of Philadelphia (CHOP), and The Hospital for Sick Children (SickKids) in Toronto have joined the multi-centre clinical trial studying the most common form of congenital heart disease, Tetralogy of Fallot or Blue-Baby Syndrome.
"We are very excited to be installing the VentriPoint Diagnostic System in our echocardiography lab in the Heart Institute at Children's Hospital Colorado and to be participating in the FDA trial. We feel this system has the potential to tremendously impact how we manage our patients with heart disease and we look forward to putting this system into everyday use", stated Dr. Bruce (Biff) F. Landeck II, assistant professor of pediatric cardiology.
The Tetralogy of Fallot clinical trial is designed to show substantial equivalency between the gold-standard MRI method, and the 2D-ultrasound VMS™ technique. Based on advice from the FDA, the study has been designed to collect images at multiple sites and to analyze them at core labs. Nationwide Children's Hospital in Columbus Ohio is the lead center for the study and the MRI core lab and the University of Nebraska has been announced as a second image-collection site. Along with the three new image-collection sites, we are also announcing SickKids will be the core lab for the VMS analysis.
To date, with only two centres, the study has enrolled 40 patients in the clinical trial, which is designed to complete 75 evaluable cases. With five centres now enrolling, the study is expected to be completed and submitted to the FDA in 3Q12 in support of regulatory approval through a 510(k) process by the end of the year.
"Enrollment has been slow as patients are reluctant to have an MRI for research purposes. Only one out of twenty patients approached agrees to volunteer. In addition, it takes several weeks to schedule the MRI," stated Dr. George Adams, CEO of VentriPoint, "This clinical experience reinforces the need for the VMS™ approach, which takes 5 minutes of patient time compared to over an hour in the MRI and can be done immediately by a sonographer without the need for patient sedation."
The VMS™ is for investigational use only in the United States and is approved for clinical use in Canada and Europe.