MEDICAL DEVICE INNOVATION - Medical Device Daily

134
Transoma’s Sleuth AT compared
against external cardio-monitors
MEDICAL DEVICE INNOVATION 2010
By OMAR FORD
Medical Device Daily Staff Writer
A new clinical trial seeks to determine which method of
monitoring for post-procedure atrial fibrillation (AF) recurrence
is more effective while comparing Transoma
Medical’s (St. Paul, Minnesota) Sleuth AT against external
event recorders.
COMPLIANCE is poised to evaluate 140 patients and is a
randomized study that is specifically designed to compare
how the previously mentioned methods can predict and
detect the number of patients who develop recurrent AF at
six months, one year and two years after an AF ablation
procedure.
“We’re hoping that [COMPLIANCE] yields more clinical
evidence that continuous monitoring is better than intermittent
monitoring,” Stella Kim, Marketing director for
Transoma Medical told Medical Device Daily.
According to the company, external monitoring
options provide much shorter monitoring durations or limited
memory capacity which is not ideal when trying to
determine appropriate ongoing therapy for my AF patients
who have undergone catheter ablation.
Also earlier studies have shown that conventional
monitoring methods cannot detect AF in all cases, and that
a prolonged duration of monitoring is required to effectively
measure the absence or presence of AF post-ablation.
Due to the asymptomatic and transient nature, paroxysmal
(sudden onset) atrial fibrillation detection does not
often occur within the bounds of the Holter monitors, event
recorders or mobile out-clinic monitoring systems (MCOT).
While Transoma isn’t sponsoring COMPLIANCE (that
honor goes to Dhanunjaya Lakkiredd, MD), the company’s
stake in the study is the effectiveness of its Sleuth AT, a
next generation device that was given FDA clearance back
in February and was launched in June.
Lakkiredd who is director of the Center for Excellence
in Atrial Fibrillation, Bloch Heart Rhythm Center (Kansas
City, Kansas) and associate editor of the Journal of Atrial
Fibrillation approached Transoma about using the device
in the study.
The Sleuth AT is subcutaneous and sits under the pectoral
region and is about the size of a 50 cent piece.
The Personal Diagnostic Manager (PDM) component of
Sleuth is a hand-held, multipurpose device that automatically
retrieves and stores relevant ECG data from the
implanted cardiac monitor (ICM), securely relays the information
to the base station and then 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. 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.
It can be programmed to capture a 20-second ECG strip
every 7.5 minutes, or every 15 minutes, or every four hours,
according to the company. So in essence, if the physician
wanted to monitor a patient for complex arrhythmias,
including AF, he or she would get a monthly report, looking
at the patient for 20 seconds as often as every 7.5 minutes.
Transoma said the system includes an implantable loop
recorder, a personal diagnostic manager, a base station and
a 24/7 monitoring center operated by Medicomp (Chantilly,
Virginia) and staffed by certified cardiac technicians who
classify and notify physicians of the presence of a wide variety
of cardiac arrhythmias such as ventricular tachycardia,
bradycardia, supraventricular tachycardia and AF.
If the cardiac technician observes a particularly concerning
arrhythmia, the patient’s physician will be contacted
immediately, the company said.
“Where our device is different from others is that we
have continuous monitoring,” Kim said. “The device is also
truly wireless unlike other offerings.”
Competitors sharing this market include, Medtronic’s
(Minneapolis) Reveal XT and its Reveal DX insertable cardiac
monitors are placed just under the skin of the chest
area in a short outpatient procedure, and are also designed
to capture an ECG during the actual episode. Another such
device is St. Jude Medical’s (St. Paul, Minnesota), Confirm
ICM – a device is the size of a computer thumb drive.
Transoma maintains that its wireless capabilities help
distinguish it from the competition and said that this new
study will change and quite possibly redefine the ICM market.
“Being a part of COMPLIANCE is huge for us,” Kim told
MDD. “There’s so much interest in this form of monitoring
and we’re grateful that Dr. Lakkiredd has included us.”
(This story originally appeared in the Sept. 30, 2009,
edition of Medical Device Daily)
To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547.
Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.