BIOTRONIK Announces Results of REPLACE Registry, the First and Largest Prospective Study of Device Replacement Includes All CRM Manufacturers

Presented at Infectious Diseases Society of America Scientific Sessions, REPLACE
Registry Analysis May Have Implications for Site Preparation and Antibiotic Use
in Device Replacement for All Types of CRM Devices from All Manufacturers
LAKE OSWEGO, Ore.--(Business Wire)--
BIOTRONIK, Inc. today announced the results from site preparation, antibiotic
use, and infection sub-analysis from the REPLACE Registry. The results, based on
analysis of 1,031 patients undergoing elective replacement of their implanted
cardiac rhythm management (CRM) device, provides important insight on techniques
for surgical site preparation and antibiotic use in device-replacement
procedures.

The REPLACE Registry was designed to evaluate the rate of complications from CRM
device replacement and upgrade from all CRM manufacturers. The REPLACE Registry
is the first large, prospective study to look at the factors that influence
infection rates in device replacement.

The sub-analysis included 1,031 replacement procedures with representative
devices from five CRM manufacturers.

The infection rates from the first group of patients in the REPLACE Registry
were presented at the poster sessions of the Infectious Diseases Society of
America Scientific Sessions. Two factors were identified that exhibited
significantly different infection rates. The first factor was preoperative skin
preparation. Skin preparation with povidone-iodine was associated with an
increased rate of infection (2.1%) compared with Chlorhexidine-containing
compounds (0.2%), p=0.013. The second factor was post-operative antibiotic use.
The incidence of infection among patients receiving no postoperative antibiotics
(0.5%) was lower than in those receiving parenteral antibiotics postoperatively
(2.3%). "Postoperative IV antibiotics are often given to patients in an attempt
to decrease the risk of infection," noted Daniel Uslan, MD, Assistant Clinical
Professor at UCLA and member of the REPLACE Registry steering committee. "In the
REPLACE Registry, there did not seem to be any benefit to doing so."

"Infections occurred uncommonly in the REPLACE Registry. It is interesting that
a variety of antibiotic prophylaxis measures were used by the site investigators
who participated," added Jeanne Poole, MD, National Principal Investigator for
the REPLACE Registry. "All patients received intravenous antibiotics. These data
will contribute significantly to the body of literature available on device
related infections."

As one of the world`s leading cardiovascular medical device companies, with
several million implanted devices, BIOTRONIK is represented in over 100
countries with its global workforce of more than 4,500 employees. Known for
having its finger on the pulse of the medical community, BIOTRONIK assesses the
challenges physicians face, and provides the best solutions for all phases of
patient care, ranging from diagnosis to treatment to patient management.
Quality, innovation and reliability define BIOTRONIK and its growing success,
and deliver confidence and peace of mind to physicians and their patients
worldwide.

BIOTRONIK, Inc.
Jay Pasquantonio, 503-675-2168
jay.pasquantonio@biotronik.com

Copyright Business Wire 2009