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Manuela Schildwächter
Tel +49 30 68905 1414
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5/26/15

One Year Data from Industry-Independent SORT OUT VII Trial Presented at EuroPCR 2015 Reveals Orsiro Is Non-Inferior to Nobori Stent in Large, All-Comers Population

New Data on BIOTRONIK Orsiro Hybrid Drug-Eluting Stent Demonstrates Enhanced Safety and Three-Times Reduced Risk of Stent Thrombosis
BUELACH, Switzerland, May 26, 2015—BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced that positive new data regarding Orsiro, the industry’s first hybrid Drug-Eluting Stent (DES), was presented at EuroPCR 2015 in Paris, France. One year results from the SORT OUT VII trial confirmed Orsiro’s non-inferiority to the bioabsorbable polymer biolimus-eluting Nobori stent in an all-comers population.

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5/22/15

Dual- and Single-Chamber Implantable Cardiac Defibrillators (ICDs) Offering Full Body 1.5 Tesla Magnetic Resonance Imaging Scans and Contain BIOTRONIK Home Monitoring

BIOTRONIK Brings Iforia 7 DR-T and VR-T DF4 Systems with ProMRI Technology to the Japanese Market
TOKYO, Japan, May 22, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology that offers the world’s largest portfolio of Magnetic Resonance Imaging (MRI) compatible cardiac implants, has announced the Japanese market release of its ProMRI Iforia 7 DR-T and VR-T DF4 implantable cardiac defibrillators (ICDs). The dual- and single-chamber Iforia 7 ICDs offer patients full-body MRI scans at standard 1.5 tesla scan strength.

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5/21/15

Sleek Device Together with Home Monitoring Allows for Earlier Therapy Adjustments in Cardiovascular Implantable Electronic Device Patients

BIOTRONIK Announces Full Release of CardioMessenger Smart 3G in Japan
TOKYO, Japan, May 21, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today the full launch of CardioMessenger® Smart 3G in Japan. The portable data-transmitter device is about the size of a smartphone. It keeps pacemaker and implantable cardioverter defibrillator (ICD) wearers connected to their physicians, enabling safer, more efficient treatment at any time, nearly anywhere in the world. Japan is the first country to introduce the new transmitter and it will be rolled out in European countries throughout 2015.

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5/20/15

Experts at BIOTRONIK-Sponsored Symposium Discussed Orsiro’s Performance in Difficult Cases as well as Coming Developments in Percutaneous Coronary Intervention

Data Presented on Orsiro Hybrid Drug-Eluting Stent at EuroPCR 2015 Highlights Safety and Efficacy in High-Risk Patients
PARIS, France, May 20, 2015—BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, today hosted a scientific symposium regarding Orsiro, the industry’s first hybrid Drug-Eluting Stent (DES). During the symposium at EuroPCR, experts emphasized a series of studies which have demonstrated Orsiro’s efficacious performance in the treatment of discrete de-novo stenotic lesions and in-stent restenotic lesions as best-in-class for high-risk patient subgroups.

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5/20/15

Le premier stent actif hybride du secteur inaugure une nouvelle classe de stents, pour une meilleure prise en charge des patients.

Le stent actif hybride à mailles ultra-fines Orsiro a obtenu les extensions d’indication par la Haute Autorité de Santé.
PARIS (France), le 20 mai 2015—BIOTRONIK, l'un des principaux fabricants de dispositifs médicaux cardiovasculaires au monde, a annoncé ce jour l’avis d’extension des indications d'Orsiro par la Haute Autorité de Santé le 21 avril 2015, le premier stent actif hybride du secteur associant un revêtement actif BIOlute et un revêtement passif proBIO. Ce nouvel avis fait suite à plusieurs études ayant démontré l'innocuité et l'efficacité d'Orsiro dans le cadre du traitement des lésions sténotiques de novo, des lésions resténotiques intra-stent, des lésions pluritronculaires, des occlusions coronaires totales et du tronc commun gauche.

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5/15/15

ProMRI Phase C Results Confirm the Safety of Iforia ProMRI Implantable Cardioverter Defibrillator in Thoracic Spine and Cardiac Scans under 1.5 Tesla MRI Scanning Conditions

BIOTRONIK Presents ProMRI ICD Clinical Study Results at Heart Rhythm 2015 Scientific Sessions
BOSTON and LAKE OSWEGO, Ore., May 15, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced that the Phase C results of the ProMRI® Clinical Study were presented at the Late Breaking Clinical Trial session of the Heart Rhythm 36th Annual Scientific Sessions (HRS).

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5/13/15

Physician and Patient Demand Validates Market Need for MRI Accessible Cardiac Implanted Devices that Facilitate Appropriate Future Care

BIOTRONIK Reports Majority of its Pacemakers Sold Have ProMRI Technology
BOSTON, Massachusetts, and LAKE OSWEGO, Oregon, May 13, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced that since the launch of the ProMRI® Eluna pacemaker system in late March 2015, 60 percent of pacing devices sold by the company are approved for use during magnetic resonance imaging (MRI) scans. The announcement was made at Heart Rhythm 2015, currently underway in Boston.

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5/12/15

Implantations in Aortic Stenosis Patients at the University Heart Center Hamburg-Eppendorf (UKE) Confirm Safety at 30 Days

BIOTRONIK Announces Successful First Implantations of Resheathable Transcatheter Aortic Valve
BUELACH, Switzerland, May 12, 2015 – BIOTRONIK, a leading manufacturer of cardio- and endovascular medical devices, announced the completion of the BIOVALVE first-in-human trial for its new transcatheter aortic valve. Study doctors successfully implanted the BIOTRONIK device in patients suffering from severe symptomatic aortic stenosis. The study, which established the transcatheter aortic valve implantation (TAVI) device’s early safety at 30 days1, was conducted at the University Heart Center Hamburg-Eppendorf (UKE), Germany.

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5/12/15

Universitätsklinikum Hamburg-Eppendorf (UKE) führt erfolgreiche Erstimplantationen bei Patienten mit Aortenklappenstenose durch

BIOVALVE-Studie belegt die Sicherheit der neuen repositionierbaren Aortenklappe von BIOTRONIK
BÜLACH, Schweiz, 12. Mai 2015 – BIOTRONIK, ein führender Hersteller kardio- und endovaskulärer Medizintechnik, gab heute die erfolgreichen Erstimplantationen seiner repositionierbaren Aortenklappe bekannt. Im Rahmen der First-in-Man-Studie BIOVALVE konnte die Sicherheit des kathetergesteuerten Systems zur Aortenklappenimplantation (transcatheter aortic valve implantation; kurz: TAVI) nach 30 Tagen bestätigt werden.1 Die Prüfärzte am Universitätsklinikum Hamburg-Eppendorf (UKE) implantierten die Klappe erfolgreich bei Patienten mit schwerer symptomatischer Aortenklappenstenose.

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5/11/15

BIOTRONIK and CFI Medical Team Up to Better Protect US Interventional Cardiologists from Occupational Risks of Radiation Exposure and Orthopedic Strain

BIOTRONIK Distributes Zero-Gravity Weightless Radiation Protection System in the US
BOSTON, Massachusetts and LAKE OSWEGO, Oregon, May 11, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced an agreement to be the US distributor of CFI Medical’s Zero-Gravity™ weightless radiation protection system. To date, more than 275 Zero-Gravity systems have been installed in hospitals around the United States.

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5/5/15

Latest Technology Defibrillator and CRT-D Devices Include Unique Sensor to Help Patients with Heart Failure Conditions

BIOTRONIK Cardiac Resynchronization Defibrillator Devices Bring Closed Loop Stimulation Sensor to US Heart Failure Patients
LAKE OSWEGO, Oregon, May 5, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that a unique physiologic sensor is now available in the latest family of cardiac resynchronization therapy defibrillator (CRT-D) devices. Closed Loop Stimulation (CLS) is the only cardiac sensor capable of appropriately adapting heart rate in response to physiologic demands independent of body movements or respiratory rate.

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5/4/15

New Patient Device Allows for Earlier Therapy Adjustments in Heart Patients with Pacemakers, ICDs, CRT and BioMonitor Devices

CardioMessenger Smart with BIOTRONIK Home Monitoring Enhances Safety for Cardiac Device Patients
BERLIN, Germany, May 4, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced the CE approval of CardioMessenger® Smart. The device, about the size of a smartphone, keeps pacemaker and implantable cardioverter-defibrillator (ICD) wearers connected to their physician enabling safer, more efficient treatment anywhere in the world.

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5/4/15

Innovatives Gerät für Patienten mit Herzschrittmachern, ICDs, CRT-Systemen und Herzmonitoren ermöglicht die direkte Vernetzung mit dem Arzt

CardioMessenger Smart mit BIOTRONIK Home Monitoring erhöht Sicherheit von Herzpatienten
BERLIN, 4. Mai 2015 – BIOTRONIK, ein führender Hersteller kardiovaskulärer Medizintechnik, gab heute die CE-Zulassung für den CardioMessenger® Smart bekannt. Das mobilfunkfähige Gerät hat die Größe eines Smartphones und vernetzt Patienten, die einen Herzschrittmacher oder implantierbaren Kardioverter-Defibrillator (ICD) tragen, direkt mit ihrem betreuenden Kardiologen.

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4/30/15

Japanese Patients Avail of Iperia 7 VR-T DX Single-Chamber ICD with Dual-Chamber Diagnostics and Approved for 3.0 Tesla and 1.5 Tesla Full-Body MRI Scans

BIOTRONIK Brings Only ProMRI Implantable Defibrillator Accepted for Ultra-High Field Imaging to World’s Largest MRI Market
TOKYO, Japan, April 30, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology that offers the world’s largest portfolio of ProMRI® cardiac implants, has announced the Japanese market release of its Iperia 7 VR-T DX ProMRI single-chamber implantable cardiac defibrillator (ICD). With its DX technology, BIOTRONIK offers the world’s only ICDs that collects full atrial diagnostic information with just one lead. It is also the first company to grant patient access to both ultra-high field 3.0 tesla (T), with an exclusion zone, and full-body magnetic resonance imaging (MRI) at standard 1.5 T scan strength.

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4/27/15

„Zero-Gravity“ heißt das neuartige Strahlenschutzsystem, das Klinikärzten erlaubt, buchstäblich unbeschwert zu operieren. Das Vivantes Klinikum Neukölln ist das erste deutsche Krankenhaus, das dieses System seit Anfang April in Betrieb genommen hat.

Schwerelos operieren – Vivantes setzt als erstes Krankenhaus in Deutschland schwebende Röntgenschürzen ein
Der von CFI Medical entwickelte und seit Ende 2014 in Deutschland zugelassene Körperschild mit Kopfvisier schützt die behandelnden Ärzte besser als zuvor: Er vermindert Ermüdungserscheinungen und orthopädische Belastungen bei Ärzten und bietet besseren Strahlenschutz als herkömmliche Röntgenschürzen.

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4/24/15

Studien belegen medizinischen und ökonomischen Nutzen des Home Monitoring für Herzpatienten - Experten fordern flächendeckenden Einsatz

Home Monitoring – Telemedizin für eine bessere und effizientere Patientenversorgung
WIEN, Österreich, 24. April 2015 – Im Rahmen eines Pressegespräches anlässlich des 20. Expertentreffens für Herzrhythmustherapie in Krems wurden die Potenziale einer telemedizinischen Fernnachsorge mit BIOTRONIK Home Monitoring® diskutiert. Diese ermöglicht es Ärzten, Patienten mit einem Herzschrittmacher oder implantierbaren Kardioverter-Defibrillator (ICD) aus der Ferne zu betreuen und frühzeitig in die Therapie einzugreifen. Bei dem Treffen kam der Frage nach einer möglichen Effizienzsteigerung durch Home Monitoring besondere Bedeutung zu – nicht zuletzt angesichts des seit Beginn des Jahres in Österreich gültigen Ärztearbeitszeitgesetzes, das eine deutliche Begrenzung der ärztlichen Arbeitszeit in Spitälern vorsieht.

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4/17/15

New BIOTRONIK DX ICDs With Longer Battery Life and 42 Joules on First Shock Offers “Maximum Energy”; Itrevia ICD Series Also Approved

FDA Approves Only ICD with Ultra-High Energy on the First Shock
LAKE OSWEGO, Oregon, April 17, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the Food and Drug Administration (FDA) has approved the only implantable cardioverter defibrillator* (ICD) that can deliver ultra-high energy on the first shock. Also included in the approval response from the FDA is the latest generation of defibrillator devices for patients with complex heart rhythm conditions.

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4/6/15

Second Generation MR Conditional Pacemakers Are the Only Offering Both Single- and Dual-Chamber Models in the US

First US Patient Implanted with BIOTRONIK Eluna Pacemaker System with Full-Body ProMRI Technology
LAKE OSWEGO, Oregon, April 06, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the first US patient has been implanted with the company’s Eluna pacemaker system with ProMRI® technology. The Eluna pacing system* allows patients to undergo full-body magnetic resonance imaging (MRI) scans.

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4/1/15

Workhorse Balloon Designed to Enhance Access to Difficult Lesions and Challenging Patient Anatomies

BIOTRONIK Announces European Launch of Pantera Pro Coronary Balloon Catheter
BUELACH, SWITZERLAND, April 1, 2015 – BIOTRONIK, a leading manufacturer of cardio- and endovascular medical devices, today announced the European market launch of the Pantera Pro semi-compliant coronary balloon dilatation catheter. The Pantera Pro workhorse balloon received CE mark in January 2015.

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4/1/15

Innovativer Ballonkatheter bietet einen verbesserten Zugang zu geschädigten Herzkranzgefäßen und komplexen Gefäßanatomien

BIOTRONIK bringt mit dem Pantera Pro eine neue Ballonkatheter-Generation zur Behandlung der Koronargefäße auf den Markt
Bülach (Schweiz), 1. April 2015 – BIOTRONIK, ein führender Hersteller kardio- und endovaskulärer Medizintechnik, gab heute die Markteinführung des Ballonkatheters Pantera Pro zur Behandlung von verengten Herzkranzgefäßen bekannt. Das Medizinprodukt erhielt im Januar 2015 die CE-Kennzeichnung und ist damit für den europäischen Markt zugelassen.

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3/20/15

Second Generation Single- and Dual-Chamber Pacemakers that Give Patients Access to MRI Scans Now Available in the US

FDA Approves BIOTRONIK Eluna Pacemaker System with Full-Body ProMRI Technology
LAKE OSWEGO, Oregon, March 20, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved its ProMRI® Eluna pacemaker system. BIOTRONIK ProMRI technology allows patients to undergo full-body magnetic resonance imaging (MRI) scans with both single-chamber (SR-T) and dual-chamber (DR-T) Eluna pacemakers when implanted with Setrox pacing leads.

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3/16/15

Study Results Presented at American College of Cardiology Scientific Session

Data Shows BIOTRONIK ProMRI Pacemakers Are Safe and Effective in Full-Body MRI Environment
LAKE OSWEGO, Oregon and SAN DIEGO, California, March 16, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced that clinical data demonstrating the safety and efficacy of its ProMRI® pacemakers has been presented. Dr. William M. Bailey, medical director of Louisiana Heart Rhythm Specialists in Lafayette, LA, discussed these results at the American College of Cardiology’s (ACC) 64th Annual Scientific Session in San Diego.

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3/3/15

Results Demonstrate Advantage of BIOTRONIK’s Passeo-18 Lux Drug-Coated Balloon Catheter for the Treatment of Superficial Femoral and Popliteal Artery Disease

BIOTRONIK BIOLUX P-I Clinical Study Published in Journal of Endovascular Therapy
BUELACH, Switzerland, March 3, 2015 – BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced today that results of its BIOLUX P-I clinical study have been published in the esteemed Journal of Endovascular Therapy.

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2/23/15

Study Results Demonstrate the Self-Expanding Astron Stent’s Safety, Efficacy and Beneficial Clinical Outcomes Following Treatment of Iliac Artery Disease

BIOTRONIK Announces Results of BIOFLEX-I Trial at the Cardiovascular Research Technologies Conference in Washington, DC
WASHINGTON, DC, US, February 23, 2015 – BIOTRONIK, a leading manufacturer of cardio- and endovascular medical devices, today announced the presentation of promising data from the iliac arm of the BIOFLEX-I clinical trial at the Cardiovascular Research Technologies (CRT) conference in Washington, DC. The BIOFLEX-I trial is designed to support Food and Drug Administration approval of the Astron self-expanding nitinol stent to treat patients suffering from common iliac or external iliac artery disease. National principal investigator for the study, Dr. Mark W. Burket, University of Toledo Medical Center, Ohio, presented results demonstrating that Astron had successfully met clinical endpoints for safety and efficacy.

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2/19/15

Last Patient Enrolled Marks Significant Step Forward in the BIOSOLVE-II Study

BIOTRONIK Advances Clinical Evaluation of Latest Generation DREAMS, World’s First Bioabsorbable Magnesium Scaffold
BUELACH, Switzerland, February 19, 2015 – BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced the completion of enrollment in the BIOSOLVE-II trial – a clinical study investigating the safety and performance of DREAMS (DRug Eluting Absorbable Metal Scaffold).

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2/19/15

Patientenrekrutierung in BIOTRONIK Studie zur Sicherheit und Leistungsfähigkeit von DREAMS abgeschlossen

Meilenstein in BIOSOLVE-II-Studie zur klinischen Prüfung des ersten bioresorbierbaren Gefäßgerüsts auf Magnesiumbasis erreicht
BUELACH, Schweiz, 19. Februar 2015 – BIOTRONIK, ein führender Hersteller kardio- und endovaskulärer Medizintechnik, gab die Aufnahme des letzten Patienten in die BIOSOLVE-II-Studie bekannt. Hierbei handelt es sich um eine klinische Studie zur Bewertung der Sicherheit und der Leistungsfähigkeit von DREAMS (DRug Eluting Absorbable Metal Scaffold), des ersten bioresorbierbaren Gefäßgerüsts auf Magnesiumbasis.

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2/17/15

Studies Validate Safety of BIOTRONIK ProMRI Devices in Patients Subjected to Head and Lower Lumbar 1.5 T MRI Scans

ProMRI Studies Confirm Safety of MR Imaging with BIOTRONIK Devices – Results Published in Heart Rhythm Journal
BERLIN, Germany, February 17, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that its ProMRI and ProMRI AFFIRM studies have been published in Heart Rhythm, the official journal of the Heart Rhythm Society. The results validate the safety testing of BIOTRONIK’s ProMRI® technology, further cementing the company as the world’s leading manufacturer of MRI conditional cardiac devices.

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2/4/15

BIOTRONIK Announces Completion of Patient Enrollment in BIOFLOW-IV Study Evaluating Safety and Efficacy of Orsiro

BIOTRONIK Announces Completion of Patient Enrollment in BIOFLOW-IV Study Evaluating Safety and Efficacy of Orsiro
TOKYO, Japan, February 4, 2015 – BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced today that patient enrollment for the BIOFLOW-IV study has been completed. The study is intended to support Japanese government approval of the Orsiro hybrid drug-eluting stent (DES), which received CE mark in 2011.

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1/21/15

Trial Examines Safety of Full-Body MRI Scans on ICDs, including DX Technology

BIOTRONIK Concludes Enrollment in Phase C of its ProMRI ICD Study
LAKE OSWEGO, Oregon, January 21, 2015 - BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that Phase C of its ProMRI® study completed patient enrollment in December 2014. This phase investigates the safety of implantable cardioverter defibrillator (ICD) devices in patients undergoing full-body magnetic resonance imaging (MRI) scans. The BIOTRONIK DX system is also included in the study that investigates the effects of cardiac and thoracic spinal scans. BIOTRONIK is one of only two companies in the U.S. currently approved to conduct these studies, which aim to broaden diagnostic options for cardiac device patients.

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1/21/15

Schülerinnen besuchen ihre Mentorinnen bei BIOTRONIK

Mehr Frauen in die Medizintechnik
BERLIN, 20. Januar 2015 – Im Rahmen der langjährigen Zusammenarbeit mit dem „Club Lise“ hießen die BIOTRONIK Mitarbeiterinnen Sofia Binias und Ulrike Heiden naturwissenschaftlich interessierte Schülerinnen am Hauptsitz des Unternehmens in Berlin-Neukölln willkommen. Die Besucherinnen erhielten einen Einblick in den Berufsalltag der beiden Physikerinnen und konnten bei einer anschließenden Werksführung hautnah miterleben, wie Herzschrittmacher und implantierbare Kardioverter-Defibrillatoren (ICDs) entwickelt und hergestellt werden.

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1/14/15

Trial to Demonstrate Efficacy of AlCath Flux eXtra Gold Ablation Catheter in Reducing the Incidence of Harmful Thromboemboli

BIOTRONIK Announces First Enrollments in New Study Evaluating Reduction of Thromboembolic Events via GoldTip Ablation
BERLIN, Germany, January 14, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today the first enrollments in its prospective, multi-center, international Reduce-TE Pilot study (Reduction of AF Ablation Induced Thrombo-Embolic Incidence). The study will assess the ability of the advanced irrigated ablation catheter AlCath Flux eXtra Gold to reduce the incidence of silent microemboli (SME). SME are a complication associated with catheter ablation of the pulmonary veins, a common treatment for atrial fibrillation (AF). The BIOTRONIK ablation catheter features a GoldTip and a 3-D irrigation system which study investigators believe can diminish the number of SME via optimized cooling, thereby improving patient safety.

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1/14/15

Studie soll die Wirksamkeit des Ablationskatheters AlCath Flux eXtra Gold von BIOTRONIK zur Reduktion der Inzidenz von mikroembolischen Ereignissen belegen

Reduziert GoldTip-Katheterablation thromboembolische Ereignisse? Erster Patient in Reduce-TE Studie eingeschlossen
Berlin, 14. Januar 2015 – BIOTRONIK, ein führender Hersteller kardiovaskulärer Medizintechnik, gab heute den Start der prospektiven, multizentrischen, internationalen Studie „Reduce-TE“ (Reduction of AF Ablation Induced Thrombo-Embolic Incidence) bekannt. Im Rahmen der Pilotstudie wird geprüft, ob der gespülte Ablationskatheter der zweiten Generation AlCath Flux eXtra Gold dazu beitragen kann, die Inzidenz von asymptomatischen mikroembolischen Ereignissen (abgekürzt SME für „silent micro-embolic events“) zu senken.

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