MoniC Study Proves BIOTRONIK Home Monitoring® Eases Clinical Routine

BERLIN, Germany, February 5, 2013—BIOTRONIK, a leading manufacturer of innovative medical technology, today announced that MoniC (Model Project Monitor Center) study results showed web-based BIOTRONIK Home Monitoring® not only improves patient care, but is also an extremely efficient and effective clinical tool. The results were published in EP Europace by Thomas Vogtmann et. al. on November 9, 2012.

Enabling physicians to remotely monitor their patients’ clinical and device status, BIOTRONIK Home Monitoring® rapidly detects anomalies in patients’ cardiac health, continuously transmits data on a daily basis and notifies medical staff with appropriate alerts.

“Previous studies such as TRUST1,2 and COMPAS3 showed that using automated daily BIOTRONIK Home Monitoring pacemaker and implantable cardioverter-defibrillator (ICD) patients improves patient care,” explained Dr. Thomas Vogtmann, cardiology practice “Am Park Sanssouci”, Potsdam. “The MoniC study demonstrates that BIOTRONIK Home Monitoring® eases the clinical routine associated with patient monitoring.”

The MoniC study, conducted at the Campus Charité Mitte, Berlin, addressed the feasibility, safety, workload and clinical usefulness of a centralized BIOTRONIK Home Monitoring® model. Consisting of one monitoring center, the Berlin Charité, and 9 satellite clinics in Germany and Austria, 62 BIOTRONIK pacemaker and 59 BIOTRONIK ICD (implantable cardioverter-defibrillator) patients were monitored.

The BIOTRONIK Home Monitoring® platform supports close interaction between a nurse with expertise in telemonitoring and the physician. The nurse’s role is to control BIOTRONIK Home Monitoring® data flow on a daily basis and filter critical events or unclear interpretations to the physician. This model has gained wide acceptance in a singular high-volume center environment whereas the MoniC study tested this approach in a multicenter setting.

Results of the study showed that centralized BIOTRONIK Home Monitoring® is reliable, beneficial and efficient: basic screening and communication of relevant arrhythmic and technical events required a total of 1.1 minutes of a physician’s time and 30 minutes of a trained nurse’s time each day per 100 patients monitored by the center.

Supported by reliable automatic data transmission from the implanted devices, satellite clinics rated 73.7% of received basic screening messages as “valuable,” with a reaction rate of 37.4% (phone call to the patient, emergency appointment, hospitalization) and an impact on treatment in 15.8%. Additionally, 67.4% of extended screening messages were rated as “valuable,” leading to a reaction rate of 27.2% and an impact on treatment in 7.6% of those patients.

The study results also showed this model may help smaller centers fully utilize Home Monitoring technology to improve pacemaker and ICD patient care—despite a limited workforce or low patient numbers.

“MoniC underlines the all-around positive impact BIOTRONIK Home Monitoring® has every day in our study clinics,” commented Christoph Böhmer, President International at BIOTRONIK. “This trial clearly demonstrates the large potential for efficiency gains and therapy improvements, which are important parameters for health care decision makers. It’s a clear win-win for both patients and physicians, no matter what size the clinic.”

About BIOTRONIK Home Monitoring®

BIOTRONIK has pioneered advances in its BIOTRONIK Home Monitoring® remote patient management system since its first clinical application in the year 2000. The system is unique because it allows continuous, automatic wireless remote monitoring of patient status and device status with daily updates—all independent of any patient interaction. The technology leads to earlier intervention, as proven by the results of the TRUST landmark trial. Today, BIOTRONIK Home Monitoring® is used extensively in more than 5,300 clinics and 56 countries worldwide.

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 5600 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 fiftieth anniversary.

For more information: www.biotronik.com

References

1 Varma et al., Circulation 2010, 122, 325–332.

2 Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428–436.

3 Mabo P. et. al., Eur Heart J 2012, 33 (9): 1105-1111.

Contact:

Manuela Schildwächter

Global Communications Manager

BIOTRONIK SE & Co. KG

Woermannkehre 1

12359 Berlin

Tel. +49 (0) 30 68905 1466

Email: manuela.schildwaechter@biotronik.com

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