Press contact

Manuela Schildwächter
Tel +49 30 68905 1414
Fax +49 30 68905 961414
E-Mail press@biotronik.com
Link to Contact Form

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.

more...

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.

more...

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.

more...

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.

more...

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.

more...

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.

more...

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.

more...

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.

more...

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).

more...

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.

more...

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.

more...

2/4/15

バイオトロニックが、オシロ(Orsiro)薬剤溶出ステントの 安全性と有効性を評価するBIOFLOW-IV 試験の症例登録を完了

バイオトロニックが、オシロ(Orsiro)薬剤溶出ステントの 安全性と有効性を評価するBIOFLOW-IV 試験の症例登録を完了
2015 年2 月4 日、心血管医療機器におけるリーディング企業であるバイオトロニック (日本本社:東京)は、日本の承認申請のために実施しているBIOFLOW-IV 試験の症 例登録が完了したことを発表しました。本試験で評価されるオシロ・ハイブリッド薬剤 溶出ステントは、2011 年にCE マークを取得した第3 世代の薬剤溶出ステントです。

more...

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.

more...

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.

more...

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.

more...

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.

more...

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.

more...

Choose Year

Use the filters to sort the available press releases:

Submit
PrintPrint Page MailE-Mail Page Text Size