Lake Oswego, Ore. - April 7, 2011 - At BIOTRONIK, patient safety is the top consideration in every decision we make. We manufacture devices that physicians and patients depend on to treat life-threatening medical conditions. In order to ensure that our efforts lead to the most reliable products of the highest possible quality, we have historically called upon the expert guidance of practicing physicians familiar with all aspects of clinical cardiac electrophysiology. In our opinion, there is no substitute for obtaining this information, and to proceed without it would significantly impact patient access to appropriate care.
Members of BIOTRONIK’s Expert Panel of physicians are called upon by members of BIOTRONIK’s product planning, marketing, engineering, clinical and management teams to provide direct input on various topics, including design, development, clinical efficacy, testing, and marketing of products specific to the cardiac rhythm management field. On the basis of these consultants’ extensive clinical experience in the fields of electrophysiology, and diagnosis and therapy of cardiac disease, these consultants support BIOTRONIK with regard to development and improvement of implantable medical devices by providing expert opinions in these fields.
Our work with physicians on the front lines of patient care has led directly to such innovations as the BIOTRONIK Home Monitoring® System, which automatically informs a physician that a patient may soon experience a cardiac crisis. Input from these clinical partners led directly to our development of the Evia pacemaker, one of the smallest pacemakers on the market, with a battery life in excess of ten years. The implication that our contractual partnership with expert cardiologists is simply to enhance sales is flatly wrong and unfair.
Recent press accounts give the false impression that BIOTRONIK seeks to improperly influence product selection through legitimate, reasonable and customary consulting arrangements with physician experts on our advisory panels. Those accounts unfairly challenge the integrity of highly trained physicians who have spent a lifetime treating patients with potentially deadly heart arrhythmias and pacing issues.
BIOTRONIK believes that the University Medical Center of Southern Nevada, one of our many hospital partners, also was treated unfairly in the recent media coverage. The hospital has demonstrated that it understands the potential for misinterpretation of consulting agreements between industry and medical professionals and has established serious ethics safeguards. Our contracts with medical professionals engaged in our expert panels clearly state the expected work that will be performed, along with the requirements for submitting and receiving payment for that work. We consider our system for documentation and management of our expert panel to be legal, ethical, transparent, and a best-practice example for the industry.
BIOTRONIK is dedicated to patient safety and physician independence when selecting the appropriate implantable device for cardiac patients. We have the utmost confidence in the quality and reliability of our products. We are dedicated to the belief that each patient be given the best therapeutic option for that patient’s unique condition. We are committed to the principle that this decision be left to the expertise of a trained physician.
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 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.