Kontakt
QR-Code für die aktuelle URL

Pressemitteilung Box-ID: 745582

BIOTRONIK Woermannkehre 1 12359 Berlin, Deutschland http://www.biotronik.com
Ansprechpartner:in Frau Manuela Schildwächter +49 30 689051414
Logo der Firma BIOTRONIK
BIOTRONIK

BIOTRONIK Announces Start of Pioneering BIOWOMEN Study

First Patient Enrolled in Global Clinical Investigation into Differences in Gender Response to Cardiac Resynchronization Therapy

(PresseBox) (Berlin, Germany, )
BIOTRONIK, a leading manufacturer of cardio- and endovascular medical devices, announced today the first patient enrolment in its BIOWOMEN clinical study. BIOWOMEN will investigate cardiac resynchronization therapy (CRT) response in women and men to evaluate if women respond better to treatment. It is the first study of its size to investigate the topic, addressing the urgent medical need for global, gender-specific clinical trials of heart failure (HF) patients.

"I am very excited to begin this groundbreaking trial," said coordinating clinical investigator Dr. María José Sancho-Tello, Hospital Universitario La Fe, Valencia, Spain. "Clinical factors linked to CRT response seem to be more present in women when compared to men, but this has not yet been proven. With the proper patient selection, we want to discover if women do indeed respond better to CRT."

In order to examine the interrelationship between gender, baseline clinical factors and CRT response, BIOWOMEN will enroll an even ratio of 247 patients of each sex in 25 centers in nine countries worldwide. Enrolment will take place over two years. There will be a one year follow-up, with results expected in 2018. The primary endpoint is response to CRT by measuring the left ventricular ejection fraction. Important secondary endpoints are baseline clinical factors, their relation to response, and QRS-complex related to CRT response.

Usually women are underrepresented in CRT and HF trials, constituting only 25 to 30 percent of patients enrolled. Nevertheless, relevant CRT trials such as MADIT CRT and CARE-HF have shown that clinical factors favoring CRT response are more present in women than in men, such as non-ischemic cardiomyopathy, hypertension, diabetes and intra-ventricular dyssynchrony.

The current disproportion of female patients in CRT and HF trials is the result of a combination of factors. Co-coordinating clinical investigator of BIOWOMEN, Dr. Lieselot van Erven, LUMC, Leiden, Holland, explained: "Women with HF also tend to have more atypical symptoms when compared to men, such as acute ischaemia.

This leads to delayed diagnosis and delayed opportunities for CRT in general." Dr. van Erven went on to say that confirming the effectiveness of CRT in women is of great importance for the female HF population and will give physicians more insight in the selection criteria. "This study could contribute to daily clinical decision-making," she added.

According to Albert Panzeri, Vice President at BIOTRONIK, providing evidence to support the best clinical care was the driving motive for creating the BIOWOMEN trial. "We understand that ideal treatment for HF patients can vary based on age, sex and medical factors, and the best way to understand the patient population is with clinical investigations," he stated. "Through BIOWOMEN we hope to gain insights into the previously unknown question: do women respond better to CRT? If they do, physicians need to know this in order to provide the best care. Providing the best possible patient care is our ultimate goal."

Website Promotion

Website Promotion

BIOTRONIK

One of the world's leading manufacturers of cardio- and endovascular 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 patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world's first 4 F-compatible 200 mm peripheral stent; Orsiro, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology.

For more information, visit: www.biotronik.com

Für die oben stehenden Pressemitteilungen, das angezeigte Event bzw. das Stellenangebot sowie für das angezeigte Bild- und Tonmaterial ist allein der jeweils angegebene Herausgeber (siehe Firmeninfo bei Klick auf Bild/Meldungstitel oder Firmeninfo rechte Spalte) verantwortlich. Dieser ist in der Regel auch Urheber der Pressetexte sowie der angehängten Bild-, Ton- und Informationsmaterialien. Die Nutzung von hier veröffentlichten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem angegebenen Herausgeber. Bei Veröffentlichung senden Sie bitte ein Belegexemplar an service@pressebox.de.
Wichtiger Hinweis:

Eine systematische Speicherung dieser Daten sowie die Verwendung auch von Teilen dieses Datenbankwerks sind nur mit schriftlicher Genehmigung durch die unn | UNITED NEWS NETWORK GmbH gestattet.

unn | UNITED NEWS NETWORK GmbH 2002–2023, Alle Rechte vorbehalten

Für die oben stehenden Pressemitteilungen, das angezeigte Event bzw. das Stellenangebot sowie für das angezeigte Bild- und Tonmaterial ist allein der jeweils angegebene Herausgeber (siehe Firmeninfo bei Klick auf Bild/Meldungstitel oder Firmeninfo rechte Spalte) verantwortlich. Dieser ist in der Regel auch Urheber der Pressetexte sowie der angehängten Bild-, Ton- und Informationsmaterialien. Die Nutzung von hier veröffentlichten Informationen zur Eigeninformation und redaktionellen Weiterverarbeitung ist in der Regel kostenfrei. Bitte klären Sie vor einer Weiterverwendung urheberrechtliche Fragen mit dem angegebenen Herausgeber. Bei Veröffentlichung senden Sie bitte ein Belegexemplar an service@pressebox.de.