Medical Device Daily

Patients are told all the time to be proactive with their health, by having annual check-ups and living a healthy lifestyle, but what if a med-tech company made a device that was proactive in the early detection of illnesses that could plague the heart.

The what-if became a reality last week when Corventis (San Jose; California), a venture-funded med-tech company started in 2005, reported FDA clearance for its AVIVO Mobile Patient Management System.

AVIVO is a non-invasive, wireless system that monitors cardiovascular conditions. It is the company's inaugural product and Corventis describes it as a platform system that helps to identify the company's fundamental technological focus.

"This is the first of two to three products we intend to launch," Ed Manicka, president/CEO of Corventis told Medical Device Daily. "AVIVO actually watches the patient and monitors the heart. What we're trying to do with the device is catch things in the patient before they occur and have an adverse effect."

AVIVO looks somewhat like a small Band Aid that is placed on the patient, but to call it that would be a grave misnomer, according to Manicka, since it could have much more than Band Aid-like impact. The company says it believes that this device could have tremendous cost saving benefits for patients and the healthcare industry as a whole.

The device utilizes the company's PiiX wearable sensor – key to the device's ability to provide continuous ambulatory monitoring – providing insight into cardiovascular health during a person's normal daily routines. The PiiX sensor automatically collects physiological information and wirelessly transmits the data from the patient to Corventis – at either its London or San Jose offices for further analysis and presentation on a secure website.

Currently electrocardiograms (ECG) and other tests performed in a hospital or clinic setting provide valuable information about the rhythm of the heart and overall patient health status. In many cases, however, it is necessary to monitor heart rhythm or other physiological signals for a longer period of time for a better understanding of the patient's condition. But this is cumbersome with many current technologies.

Because it has no leads and wires, PiiX encourages patient-friendly, continuous wear, and it can be worn even while showering or sleeping. Automated collection and transmission of data also minimizes the number of steps required by the patient to ensure reliable event detection, according to the company.

Corventis says that its wireless technology offers "ongoing visibility" into a patient's cardiac health status, previously accessible primarily with invasive implantable devices.

Multiple sensors on the PiiX enable what the company calls "intelligent detection" of clinical events and the creation of "comprehensive heart rate, respiratory rate, fluid status, and posture and activity trends. Clinical event information such as ECG is captured on an "exception" basis, according to the company, providing focused review and diagnosis by clinicians.

There is a huge market for the device. More than two million Americans have atrial fibrillation, a cardiac arrhythmia increasingly being seen as putting a person at risk for stroke. And nearly 835,000 Americans are discharged from hospital care with cardiac arrhythmia diagnoses each year.

Corventis was founded to primarily serve the cardiac health market – thereby deriving its name.

"'Core' is Latin for heart, and ventis' stands for innovation," Manicka said. "So Corventis means to be at the heart of innovation."

The company is funded by venture capital firms Kleiner, Perkins, Caufield & Byers, Mohr Davidow Ventures and DAG Ventures.

"We are very proud of our accomplishments to date, including filing more than 50 patents internationally, deploying our solutions around the globe, successful enrollments in our clinical program and receiving this FDA clearance for our technology. The elegant solution we have developed will serve as a platform for multiple future products designed to improve the way heart conditions are managed," Manicka said.

"I see us fundamentally transforming healthcare by adding the Internet into the management process."

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