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FDA Approves First Single-Lead ICD with Atrial Sensing

  FDA Approves First Single-Lead ICD with Atrial Sensing

BIOTRONIK’s Lumax DX System Could Help the 50,000 Patients Each Year Who May
Benefit from Atrial Sensing, without Pacing Indication

Business Wire

LAKE OSWEGO, Ore. -- February 25, 2013

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.

BIOTRONIK's Lumax DX System is a first-in-class implantable cardiac
defibrillator (ICD) that utilize ...

BIOTRONIK's Lumax DX System is a first-in-class implantable cardiac
defibrillator (ICD) that utilizes a single lead with atrial sensing
capabilities. (Photo: Business Wire)

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 70,000^1 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,^2 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^3 or a stroke^4 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^smart S DX lead. Based on proven technology, the
Linox^smart 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.^5”

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,^6 and device related issues,^7 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.

About BIOTRONIK SE & Co. KG

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^th anniversary.

For more information, visit: www.biotronik.com

^1 Biotronik data on file

^2 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.  J Am
Coll Cardiol.. 2011 Aug 30;58(10):1007-13. doi: 10.1016/j.jacc.2011.04.039.

^3 Daubert, JP. Et al; Inappropriate implantable cardioverter-defibrillator
shocks in MADIT II, JACC 2008; 51: 1357-6.

^4 National Stroke Association. Controllable Risk Factors – Atrial
Fibrillation. 2013. http://www.stroke.org/site/PageServer?pagename=afib

^5 Biotronik data on file

^6 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

^7 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

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Contact:

Global:
Manuela Schildwächter
Global Communications Manager
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin
Tel. +49 (0) 30 68905 1466
Email: manuela.schildwaechter@biotronik.com
or
U.S.:
Krystin Hayward/Brianne Donahue
Schwartz MSL Boston
781-684-0770
Email: biotronik@schwartzmsl.com