Transoma Medical Receives FDA Marketing Clearance for Exclusive Capability Providing Immediate Access to Critical ECGs on Mobile Handheld Device

Full commercial launch of Sleuth AT™ Implantable Cardiac Monitoring System
underway with clearance of instant Data Review capability
ST. PAUL, Minn.--(Business Wire)--
Transoma Medical, Inc., manufacturer of Sleuth® and Sleuth AT™, the only
wireless and automated implantable cardiac monitoring (ICM) systems has received
FDA 510(k) marketing clearance for its new Data Review feature on Sleuth AT. The
Data Review feature allows any clinician to easily access up to 99 events stored
on the patient`s Personal Diagnostic Manager (PDM). The PDM is a handheld device
that retrieves and stores ECG data from the implanted device prior to automatic
transmission to the 24/7 monitoring center. Each stored ECG strip is labeled
with the time and date of the cardiac event making it easier for clinicians to
correlate symptoms with rhythms.

"Instant access to a patient`s ECG data on the mobile handheld device is a
clinically valuable tool in urgent situations, such as when the patient presents
in the emergency room," said Dr. Asim Yunus, an electrophysiologist with
Michigan Cardiovascular Institute in Saginaw, Mich. "Transoma continues to
advance cardiac monitoring technology with their devices. The Sleuth systems
already provided information much faster and more efficiently than other
implantable monitoring options. Now, with Data Review, we don`t even have to
wait for the automatic downloads to the monitoring center because the events are
right there on the handheld device. This kind of access to information has never
been available before."

As a complete, remote and automated system, Sleuth AT offers several advantages
over other available implantable monitoring products. The system includes a
small implanted device that incorporates the most sensitive arrhythmia detector
of any ICM on the market. Not only does Sleuth AT capture ECG strips containing
arrhythmias automatically, it also allows the patient to capture data by
pressing a button on the handheld PDM after experiencing a symptom. All data
captured by the implanted device is automatically transferred to the PDM,
providing an additional 10.5 hours of ECG storage. Data stored on the PDM is
automatically transmitted to a 24/7 monitoring center where certified cardiac
technicians review the data and alert clinicians to clinically-significant
events, providing a high degree of specificity. And now, with Data Review, ECG
recordings that have not yet been transmitted to the monitoring center can be
accessed directly on the handheld PDM.

"As a device clinic coordinator, it is not uncommon for me to manage data on
2,000 or more patients at a given time from a variety of cardiac monitoring
systems," said Lori Fravel, BSN, CCRN, CCDS, a nurse who supports 10
cardiologists at Mt. Carmel Columbus Cardiology Consultants in Columbus, Ohio.
"I have found the Sleuth systems to be extremely efficient because I am only
alerted to clinically-significant events and I never have to call the patient to
coordinate manual interrogation of his or her device. The setup of the system
allows me to get the information I need in a much more streamlined fashion. Now
with Sleuth AT, the added benefit of ECG access on the handheld device means any
available clinician can view recently captured events without a programmer, even
if the patient has been away from home. I am hopeful this will further speed
access to critical information."

"With the addition of the Data Review feature, the Sleuth AT system is designed
to be an even better and more accurate diagnostic tool that further enhances
efficiency for the practice and simplicity for the patient," said Nestor
Jaramillo, Transoma Medical vice president of sales and marketing. "Our goal is
to assure that clinicians have access to the right cardiac information at the
right time in the simplest and most efficient manner possible. Providing the
right information to the physician can lead to faster diagnosis and selection of
the right therapeutic regimen for the patient. Everyone can benefit. At Transoma
Medical, we believe better treatment starts with better information."

The Sleuth AT System

* The Implantable Cardiac Monitor is a small, thin device, about the size of a
50-cent piece (or the size of the smallest pacemakers), which continuously
monitors the electrical activity of the heart, the ECG. The cardiac monitor is
implanted under the skin during a brief, simple, outpatient procedure.
* The Personal Diagnostic Manager (PDM) is a hand-held, multipurpose device that
automatically retrieves and stores relevant ECG data from the implanted cardiac
monitor and securely relays the information through a base station to the
monitoring center. The PDM is also used by the physician to program the
implanted cardiac monitor and even to view non-transmitted ECGs immediately
after capture. Data are collected in three ways:

* Patients who experience symptoms, such as lightheadedness, can press a button
on the PDM which tells the system to store the patient`s ECG strip during the
time of the symptom.
* The system automatically captures and stores the ECG strip when the patient`s
heart rate is above or below physician-programmed limits.
* The system can be programmed to capture regular ECG strips every four hours,
15 minutes or 7.5 minutes.

* At the third-party Monitoring Center, certified cardiac technicians review the
patient`s ECG data and provide information to the physician to aid in diagnosis
and ongoing treatment. Physicians can access this information via a secure Web
portal, and have the reports faxed or e-mailed to them as they prefer. If the
cardiac technician observes a particularly concerning arrhythmia, the patient`s
physician will be contacted immediately.

About Transoma Medical

Transoma Medical, Inc., headquartered in St. Paul, Minnesota, is a medical
technology company engaged in developing, manufacturing and distributing
implantable, wireless diagnostic and monitoring products. Transoma is focused on
monitoring systems that provide physicians with vital signs information
important to accurately diagnose and monitor various forms of cardiovascular
disease, and to optimize drug, interventional, surgical and device treatment
alternatives. For more information, visit the company`s Web site at
www.transoma.com.

Transoma Medical, Inc.
Brian Brockway, 651-481-7444
bbrockway@transomamedical.com
or
Padilla Speer Beardsley
Nancy A. Johnson, 612-455-1745
njohnson@psbpr.com
or
Nick Banovetz, 612-455-1705
nbanovetz@psbpr.com

Copyright Business Wire 2009