MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
FDA gives green light for AVIVO
cardio-monitoring by Corventis
By OMAR FORD
Medical Device Daily Staff Writer
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 medtech
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 having 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.”
(This story originally appeared in the April 30, 2009,
edition of Medical Device Daily).
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