Ventripoint VMS+ device offers MRI-quality 4-chamber analysis of the heart
FDA approval last week of Ventripoint Diagnostics’ (TSXV:VPT) VMS+ medical device with a four-chamber heart analysis system Is expected to change the paradigm of diagnosing and managing heart patients through a five-minute procedure that can be read in a cardiologist’s office in 10 minutes.
“VMS+ is the first simple echocardiography system to be approved by the FDA for the 3D volumetric analysis of all four chambers of the heart using 2D ultrasound,” CEO, Dr. George Adams, says in an interview with BioTuesdays.
“We can now offer VMS+ to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment,” he adds.
Dr. Adams explains that measurements of heart function, expressed as ejection fraction or the volumes of any of the four chambers of the heart, are increasingly recognized as critically important in monitoring the heart and predicting outcomes of patients.
“This applies to patients with heart failure, abnormal heart rhythms, congenital heart disease, pulmonary hypertension and hypertension,” he points out. “With the VMS+, it is now possible to obtain this valuable information quickly, easily and cost effectively.”
Ventripoint’s first generation VMS system is the only 2D echocardiography approach certified equivalent to MRI for right ventricle analysis. It has been approved by the FDA, Health Canada, and has CE Mark in Europe for all patients.
“There is no fundamental difference in how our VMS and VMS+ work other than VMS measures changes in the right ventricle only, while VMS+ measures all four chambers of the heart,” he adds.
The company’s right ventricle VMS device currently has an installed base of more than 20 major hospitals in North America, Europe and China, some of which have participated in Ventripoint’s clinical trials.
Dr. Adams says the company’s marketing plan will involve targeting key opinion leaders in the cardiovascular sector as well as centers of excellence such as the Mayo Clinic, MD Anderson Cancer Center, Cleveland Clinic and major hospitals in regional clusters, including Chicago, New York, Houston and California. “We’re hoping to announce a couple of orders before the end of the month.”
Key opinion leaders have validated the VMS technology in numerous peer-reviewed articles, including in the Journal of the American Society of Echocardiography.
Among other things, researchers have concluded that VMS gives accurate results even with complex and unpredictable shape variations in adult congenital heard disease patients with right ventricle-to-pulmonary conduits.
In addition, VMS has been shown to have excellent reproducibility even with complete retesting by different examiners in patients with pulmonary hypertension and is superior to conventional 2D echo analysis.
According to Dr. Adams, cardiologists need volumetric information on all four chambers of the heart because the left atrium is involved in heart attacks and blood pressure control; the left ventricle in chronic heart failure; the right atrium in electrophysiology and pacemakers; and the right ventricle in pediatric conditions, pulmonary hypertension and cancer therapeutics.
“Cardiologists now will have a convenient, easy-to-use method of determining whether patients need more therapy, less therapy or no therapy at all,” he contends. “They will be able to sort patients that need a simple medicine or a more complex medicine and whether patients need dual therapy or triple therapy. Cardiologists are not going to order a MRI every time they want to change your medication because there aren’t enough MRI machines and the cost would drown the system.”
The VMS+ system received Health Canada approval in 2017 and CE Mark at the beginning of 2018. Ventripoint also has established a joint venture in China to manufacture and distribute VMS+, following regulatory approval in China expected by mid-2018.
Dr. Adams points out that the number of people with hypertension is increasing, and an estimated 44% of the 64 million U.S. adults with hypertension did not have this condition controlled in 2014. “As a result, there is an enormous potential for improving population health by expanding treatment and improving outcomes.”
Controlling hypertension could prevent some 56,000 cardiovascular events and 13,000 deaths a year and also would result in significant cost savings for the healthcare system, he adds.
“For example, accurate and reliable repeat measurements of left atrium volume would inform the cardiologist which patients need to have their therapy changed to obtain greater stability of blood pressure,” he contends.
Even during pregnancy, Dr. Adams says it is difficult to determine how the mother’s heart is coping with the 40% increased load in the third trimester. “Normal volumetric index curves would enable cardiologists to determine if the heart is unusually large to determine whether a high-risk pregnancy has developed.”
The economic benefit of VMS technology also extends to cancer patients because most chemotherapies impact the heart. According to a study published in 2016 in the peer-reviewed journal, Echo Research and Practice, right heart function deteriorates in breast cancer patients undergoing anthracycline-based chemotherapy.
“We’re hoping to further study how our device can determine the impact of these adverse effects on right and left heart function,” he adds.
Ventripoint also is studying how VMS can read cardiac ultrasounds without the use of contrast media infusions. Currently, 30% to 40% of cardiac ultrasounds are unreadable and blurry, which requires the use of contrast media to get readable outcomes, Dr. Adams points out.
But upping the use of contrast media infusions is expensive, dangerous and time consuming, and requires an IV technologist to attend the ultrasound. “In the 10% of cases, even when contrast media is used, study is still unreadable, VMS should be able to analyze the study and get results,” he adds.