FDA Approves First Single-Lead ICD with Atrial Sensing

By editor
Published: February 25th, 2013

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--
BIOTRONIK, a leading manufacturer of cardiovascular medical technology,
announced the Food and Drug Administration (FDA) has granted final
approval for the BIOTRONIK Lumax 740 DX System. This novel device is a
first-in-class implantable cardiac defibrillator (ICD) that utilizes a
single lead with atrial sensing capabilities.

Single-chamber ICDs are sophisticated electronic devices that utilize a
thin flexible wire, known as a lead, to deliver an electrical shock to
the heart when the heart rate becomes dangerously fast. For patients who
have, or are at risk of developing atrial fibrillation (AF), a physician
may consider implanting a dual-chamber ICD, which utilizes two leads and
has pacemaker functions built in. For the more than 70,000
patients in the U.S. who receive an ICD each year, device selection
remains controversial.

“Until now, our only option to obtain important and useful atrial signal
information from patients undergoing defibrillator implantation has been
to implant a separate atrial lead. Implanting multiple leads in the
heart has been shown to increase the risk of complications,
and the use of dual-chamber devices in patients without a clear
indication for the additional atrial lead has received a great deal of
attention in recent months. Until now, my approach for patients who do
not require atrial pacing has been to implant single-chamber ICDs,” said
Bradley P. Knight, M.D., Medical Director, Center for Heart Rhythm
Disorders at Northwestern Memorial Hospital’s Bluhm Cardiovascular
Institute. “The DX System addresses a significant gap in ICD therapy.
Patients now have access to the benefits of both dual and single-chamber
ICDs without the risk of additional hardware.”

Traditional standard single-chamber ICDs come with limitations. The
devices are designed only to sense changes in ventricular rhythm and are
unable to sense atrial arrhythmias, such as AF, correctly. This can
result in an increased risk of an inappropriate shock or a
stroke if AF is not detected.

The DX System expands the diagnostic capabilities of a standard
single-chamber ICD with a single lead, in addition to featuring
sophisticated sensors that allow for atrial monitoring and enhanced
arrhythmia diagnosis. The system utilizes the Linox S DX
lead. Based on proven technology, the Linox S DX
utilizes an innovative floating atrial dipole. This allows physicians,
for the first-time in an ICD, to capture atrial sensing capabilities
with one lead. When combined with the Lumax 740 VR-T DX device—which has
optimized circuitry—the system provides a reliable atrial signal.
Additionally, its SMART Detection algorithms discriminate
supraventricular tachycardias (SVTs), AF and atrial flutter to reduce
the risk of inappropriate shocks.

“Electrophysiologists have long searched for effective diagnostics and
disease management capability with a less invasive treatment. But the
increased regulatory and financial obstacles associated with bringing
innovative technology to market was a challenge,” said Thomas Ahern,
M.D., Director of Cardiac Electrophysiology Research at Scripps Clinic.
“BIOTRONIK’s commitment to nearly a decade of research for this system
has provided electrophysiologists with technology that will allow for
better management of cardiac rhythm care for our patients.”

“The DX System is designed with the patient in mind,” said Paul
Woodstock, Executive Vice President of Sales and Marketing at BIOTRONIK,
Inc., USA. “Expanding on the benefits of single-chamber ICDs, the DX
System provides physicians with atrial sensing and home monitoring
capabilities to monitor for important atrial conditions such as AF. We
believe the system has the potential to be appropriate for more than
50,000, or 71 percent, of U.S. patients who receive an ICD.”

The DX System also integrates with BIOTRONIK Home Monitoring,
allowing physicians to remotely follow their DX patients’ clinical and
device statuses daily—at anytime, anywhere in the world. The
cellular-based system has demonstrated the ability to detect clinically
relevant events, including silent, asymptomatic arrhythmias,
and device related issues, allowing for earlier medical
intervention. The diagnostic capabilities of the DX System combined with
Home Monitoring makes this a simple, yet sophisticated
system for cardiac rhythm management.

The DX System is now approved and currently available in most
international markets (e.g. E.U., Japan). BIOTRONIK expects to begin
U.S. implants in late February/early March.

As one of the world’s leading manufacturers of cardiovascular medical
devices, BIOTRONIK is headquartered in Berlin, Germany, and represented
in over 100 countries by its global workforce of more than 5,600
employees. Several million heart patients around the world have received
BIOTRONIK implants, designed to save and improve the quality of their
lives. Since its development of the first German pacemaker in 1963,
BIOTRONIK has launched several innovations into the market—including
remote monitoring with BIOTRONIK Home Monitoring in 2000 and
the world’s first implantable cardioverter-defibrillators and
implantable heart failure therapy devices with ProMRI
technology, approved for MR scanning, in 2012. This year BIOTRONIK is
celebrating its 50 anniversary.

: www.biotronik.com

Biotronik data on file

Dewland, TA. Dual-chamber implantable
cardioverter-defibrillator selection is associated with increased
complication rates and mortality among patients enrolled in the NCDR
implantable cardioverter-defibrillator registry. 2011 Aug 30;58(10):1007-13. doi:
10.1016/j.jacc.2011.04.039.

Daubert, JP. Et al; Inappropriate implantable
cardioverter-defibrillator shocks in MADIT II, 2008; 51:
1357-6.

National Stroke Association. Controllable Risk Factors –
Atrial Fibrillation. 2013. http://www.stroke.org/site/PageServer?pagename=afib

Biotronik data on file

Varma N, Epstein AE, Irimpen A, Schweikert R, Love C, for
the TRUST investigators. Efficacy and safety of automatic remote
monitoring for implantable cardioverter-defibrillator follow-up: The
Lumos-T safely reduces routine office device follow-up (TRUST) Trial.
Circulation. 2010;122:325-332

Varma N, Michalski J, Epstein AE, Schweikert R. Automatic
remote monitoring of implantable cardioverter-defibrillator lead and
generator performance: The Lumos-T safely reduces routine office device
follow-up (TRUST) Trial. Circulation Arrhythmia and Electrophysiology.
2010;3:428-436

Manuela SchildwächterGlobal Communications
ManagerBIOTRONIK SE & Co. KGWoermannkehre 112359
BerlinTel. +49 (0) 30 68905 1466Email: manuela.schildwaechter@biotronik.comorKrystin
Hayward/Brianne DonahueSchwartz MSL Boston781-684-0770Email:
biotronik@schwartzmsl.com

Source: BIOTRONIK

»