Lake Oswego, Ore. - April 13, 2009 – BIOTRONIK, Inc., announced today the first U.S.implant of the next-generation Lumax 540 Series defibrillator for treating patients with heart failure. The Lumax 540 Series was recently approved by the U.S. Food and Drug Administration (FDA).
The Lumax 5 Series represents the latest devices from BIOTRONIK in its full-line of patient-focused Cardiac Rhythm Management (CRM) products engineered for electrophysiologists who demand superior quality and reliability.
The first U.S. implant of the new Lumax 540 Series was performed by Leon Feldman, M.D., FACC, co-director of Electrophysiology and Cardiology section chief at Eisenhower Medical Center in Rancho Mirage, California.
Dr. Feldman commented, “The patient presented with very complex needs: ongoing bradycardia, recurrent ventricular tachycardia, and progressive heart failure all at once. The patient will benefit from the advanced capabilities of the Lumax 5 Series defibrillator.”
Heart failure is on the rise in the U.S., affecting 5 million people with 550,000 new cases each year. Fortunately, therapies are available to enhance the quality of life of a heart failure patient.
“The patient already received the highest dose of beta blockers and ACE inhibitors that he could handle and was still in severe heart failure,” Dr. Feldman said. A cardiac resynchronization therapy defibrillator (CRT-D) was the perfect solution. “I’ve had great success with previous-generation BIOTRONIK devices and have confidence in the construction of the device and lead technology. Also, I’m a big proponent of Home Monitoring® for the patient, which can remotely and rapidly detect onset of atrial fibrillation, for which this patient is at risk.” Dr. Feldman described the benefits that BIOTRONIK’s Home Monitoring® system offers him and the patient, “It will also help us with early notification of VF and VT, which allows us to modify therapy and avoid unnecessary shocks.”
Lumax 540 Series exemplifies BIOTRONIK’s dedication to innovative programming solutions, painless, more accurate therapy, mobile monitoring, and unbeatable device longevity – all to help provide peace-of-mind for the patient. This individualized therapy management helps to reduce unnecessary follow-ups and prevent serious clinical events.
The addition of Lumax 540 Series to the BIOTRONIK, Inc. full-line of Cardiac Rhythm Management products reaffirms the company’s commitment to quality and patient care. “We are excited to be able to extend the benefits and of this new series of ICDs and CRT devices to electrophysiologists and their patients in the U.S.,” stated Rex Richmond, Vice President, Marketing for BIOTRONIK, Inc. “The Lumax 5 Series continues the legacy of demonstrated quality and reliability that electrophysiologists have come to expect and rely on from BIOTRONIK products. The introduction of Lumax 5 Series reinforces and strengthens BIOTRONIK’s foothold in the U.S. market.”
Contact: Holly Scerbo
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.