Medrtonic announced a new clinical trial to determine the safety and efficacy of an implantable cardioverter defibrillator (ICD) combined with a sensor that continuously records pressure inside the heart, potentially alerting
physicians to potential heart-failure complications before they worsen.
(press release).

The investigational device, known as the Chronicle(R) ICD, features
both the traditional ICD's ability to restore normal heart rhythm
following a dangerously fast heartbeat and the first-ever real-time
tracking of pressure inside the heart, body temperature, patient
activity and heart rate 24 hours a day. Patients implanted with a
Chronicle ICD will transmit that information from home, using a
standard phone line, to their physicians who view the recorded data
from a secure Web site in their office and then potentially make
changes to patients' medications or diet.

Along with their competitors, Medtronic is working to leverage implants as sensor platforms for chronic disease management. The first logical target is congestive heart failure.

In addition to Chronicle ICD, Medtronic has pioneered several cardiac
rhythm and disease management technologies, both investigational and
FDA approved, which monitor patients' heart functions and allow
cardiologists to make immediate care decisions based on this
information. Some of Medtronic's pioneering devices include the
following:

-- Concerto(TM) AT Cardiac Resynchronization
Therapy-Defibrillator. Medtronic's Concerto(TM) CRT-D with Atrial
Therapies (AT) is an investigational heart-failure management device
designed to automatically and wirelessly delivers information from a
patient's device to the physician's office.

-- OptiVol(TM)
Fluid Status Monitoring. Available in select Medtronic CRT-D devices,
this diagnostic feature helps manage and detect worsening heart failure
by measuring the pulmonary fluid build-up in the thoracic (lungs and
heart) cavity.

-- Reveal(R) Insertable Loop Recorder. The
world's only implantable cardiac monitor that captures and stores the
heart's rate and rhythm to determine if fainting, dizziness,
palpitations or unexplained seizure-like episodes are related to a
heart-rhythm problem.

-- Medtronic CareLink(R) Network. An
Internet-based heart-monitoring system that enables patients with
implantable devices to transmit data from their device, while at home
or traveling, to their physician using a portable monitor that is
connected to a standard telephone line.

With a cost of $25.8 billion in 2004 and more than a million hospital admissions per year, congestive heart failure is an attractive target for medical device vendors. Any meaningful reduction in admissions could result in significant reductions in health care costs. A key to success will be the end to end connectivity - something that's simple and unobtrusive for patients, and conveys meaningful data and alarms to clinicians.