Each year, 27 million adults across the globe are diagnosed with congestive heart failure, and the number is projected to increase by 47 percent by 2030. Congestive heart failure is a chronic, incurable illness that worsens over time and is associated with frequent hospitalizations.
To help manage the disease better, Vectorious Medical Technologies has developed the V-LAP system based on a miniature, battery-free sensory device positioned in the heart’s left atrium. The implant measures the pressure in the left atrium (LAP), which is known by the medical community as the earliest indication of heart failure decompensation. By having this data on a daily basis, physicians can provide the appropriate treatment to their patients and stop the deterioration before the disease’s symptoms appear.
In its early days as a small startup with limited resources, Vectorious focused on developing its complex product. It didn’t have in-house resources to address scalability and security requirements. “We knew we needed to find a way to overcome gaps in technology and ensure compliance with HIPAA and GDPR regulations,” says Keren Raiten, head of marketing for Vectorious Medical Technologies. “We wanted to achieve a fully functioning solution that could be implanted in patients as soon as possible.
Vectorious addressed its challenges by developing a device on the BioT IoMT Platform, combined with the Amazon Web Services (AWS) Cloud. The BioT cloud platform enables fast, end-to-end connectivity for Internet of Medical Things (IoMT) devices and mobile apps, and meets HIPAA, GDPR, and other regulatory compliance requirements.
The BioT platform runs on Amazon Elastic Compute Cloud (Amazon EC2) instances. V-LAP sensor data from left atrial pressure readings streams from a phone gateway via HTTPS to Amazon Elastic Load Balancing and Amazon Elastic Container Service (ECS). Pressure-reading data is stored in Amazon Aurora databases. Patient caregivers access the data in a central data repository via dashboards. “By using AWS, we can enable scalability and compliance as well as many security services such as AWS Key Management Service and AWS Web Application Firewall (AWS WAF) for the customers that use our platform,” Vinograd says.
BioT enhances security for Vectorious through the built-in HIPAA and GDPR regulatory compliance capabilities. “These capabilities help us reduce our cybersecurity risk and avoid penalties or even device recall from failure to comply,” says Raiten.
Using the BioT platform on AWS, Vectorious accelerated its development time for V-LAP because it did not need to create and integrate its own IoT connectivity and security solutions. As a result, Vectorious received approval for the device from a Declaration of Helsinki ethics committee on its first attempt. The Declaration of Helsinki manages device approvals for human trials. By saving development time, Vectorious was able to move faster to launch its clinical study in Europe. “We currently have V-LAP implanted in nine patients, with more scheduled,” says Raiten. “We are moving down the path to full regulatory approval in Europe and deployment to many more heart failure patients.”
With the V-LAP, physicians will be able to receive daily pressure measurements from the patient’s heart, identify trends, and adjust medication dosages accordingly. Vectorious expects V-LAP to improve the lives of congestive heart failure patients worldwide. “We believe V-LAP can slow down the deterioration of heart failure and reduce hospitalizations,” says Raiten. “V-LAP will be a game-changer, helping millions of people living with heart failure to take control and manage their disease. It can keep them stable and out of hospitals and help them live longer, fuller lives.”