Biotronik® is a leading European company in the field of biomedical technology. We focus on devices for vascular intervention and electrotherapy of the heart. In the latter space, Biotronik offers ablation therapy technology that uniquely incorporates a golden electrode and auto cool that has a significantly higher acute procedural success rate in bidirectional block induction. Biotronik’s 2008 acquisition of VascoMed has helped them to further supplement the product portfolio of ablation devices and beyond says Mr. Michael Gellhaus, Director of Electrophysiology for Biotronik. Mr. Gellhaus joined Biotronik as Director of their global Electrophysiology business in October 2007. He explained that the company was founded in 1963 by Prof. Dr. Max Schaldach, who developed the first German implantable pacemaker. In more recent history, in the 1990s, Biotronik expanded its product range with implantable defibrillators. Innovations produced around that time included Closed Loop Stimulation, allowing for the integration of the pacemaker into the body’s natural regulatory system, and fractal coating of implantable leads, which was also based on a principle of nature. Fractal coating, still offered exclusively by Biotronik, optimises the lead’s electrically active surface, critically improving its electrical sensing and pacing properties. Innovative technologies also improved treatment success in the area of vascular intervention. Biotronik’s absorbable metal stent (AMS) is performing successfully in the testing phase. Another research project focuses on drug-eluting stents, which contributes to the targeted prophylaxis of restenoses through the release of drugs. In the 1990s, the company also added diagnostic and therapeutic catheters as well as a radio-frequency generators for ablation to its product range further developing the work started in the 1970’s, and now offers a complete product portfolio for electrotherapy for the heart, the area in which Mr. Gellhaus operates. Biotronik’s electrotherapy business offers diagnostic tools and options for treating arrhythmias. Interesting to note in that regard is that while the purpose of first-generation pacemakers was to save patients’ lives, modern implants fulfil a broad range of functions. Improving the patients’ quality of life and monitoring the heart using diagnostic features are becoming increasingly important. Biotronik’s other key area of business is vascular intervention. Mr. Gellhaus says that atrial fibrillation is a clear strategic focus now for Biotronik. Activities have significantly expanded in this area after the acquisition of Vascomed in 2008. In 2003, Biotronik and Vascomed first established a strong joint relationship in the commercialisation of EP catheters, devices used for the invasive treatment of cardiac rhythm disorders. A direct result of Vascomed actually becoming part of Biotronik was the expanded development of new therapy solutions for the treatment of Atrial Fibrillation (AF), a growing cardiac rhythm disease which affects almost seven million people worldwide. Conventional treatment of AF typically comprises drug therapy, which provides limited long-term benefit with a potential of creating serious side effects. A catheter based ablation of pro-arrhythmic areas within the atria is currently the only curative therapeutic approach/ AF ablation represents the fastest growing segment within the Cardiac Rhythm Disease market and the Vascomed acquisition considerably strengthened Biotronik’s position in this space with the ability to offer complete therapy solutions to patients with complex cardiac rhythm diseases. “Today we’re one of few European based companies in this space with a strong international focus, most of our competitors are American,” says Mr. Gellhaus. He goes on to explain that the added value Biotronik brings to catheter technology undoubtedly is the gold tip catheter. Due to increased heat conductivity, ablation catheters with a tip electrode made of a new gold alloy can bring about deeper lesions than traditional catheters with platinumiridium electrode material. That is good news for both physicians who treat atrial flutter and patients suffering from it. This condition is often treated with medication. However, the cause of atrial flutter cannot just be treated with drugs. Ablation therapy, on the other hand, is an established curative method for this ailment. Ablation therapy targets and destroys a special tissue region in the heart, thereby preventing atrial flutter. The affected tissue is comparatively large. Therefore, the Biotronik gold tip catheter has enormous potential as the ablation time for treating atrial flutter could be significantly decreased. The technology is exclusive to Biotronik and the company continues to advance it. They recently announced the CE Mark and completion of the first successful cardiac ablation clinical case with the Trignum Flux magnetic irrigated gold tip catheter. The first clinical case was successfully performed by Karl-Heinz Kuck, director of the cardiologic center at the Asklepios Klinik in Hamburg, Germany, said Biotronik. During this case a patient who presented with a comorbidity of atrial fibrillation and atrial flutter was successfully mapped and ablated in both atrial chambers of the heart. Biotronik describes the Trignum Flux magnetic irrigated gold tip catheter as a highly flexible ablation device equipped with three magnets at the distal end. Its complementary flexibility combined with the computer-aided magneticguided Stereotaxis Niobe System reportedly ensures a precise, stable, sensitive and reproducible catheter positioning. The safety of the device is further enhanced by the catheter’s unique irrigated gold tip electrode with high thermal conductivity. Mr. Gellhaus again emphasises that transvenous catheter ablation has become the therapy of choice for patients with recurring, isthmusdependent right atrial flutter. Achieving bidirectional conduction block in the cavotricuspid isthmus is decisive for both acute and long-term therapy success and essentially depends on the selected ablation method and the lesion size. By using an 8 mm tip electrode instead of a conventional 4 mm electrode, deeper lesions can be made, thus significantly reducing the required number of energy applications for achieving a bidirectional conduction block. Experimental studies have proven that using an ablation electrode made of gold alloy allows the creation of deeper lesions than with conventional platinum-iridium electrodes. Due to the greater heat conductivity of the gold alloy as opposed to platinum-iridium, the cooling of the ablation electrode is improved and more electric energy can be transmitted to the tissue at identical temperatures. The combination of both technologies in the form of an 8 mm-long gold electrode anticipates that the lesion depth required for an isthmus block can be achieved more quickly in comparison to the platinum-iridium electrode. Now that Biotronik has the CE mark for the Trignum Flux, the company could start its fully-fledged commercialisation but Mr. Gellhaus points out that they won’t. “We will first test at 10 research centres for pre-marketing evaluation on fifty cases. Once we’ve investigated those results, we’ll move on to the next step. We want to make absolutely sure that we get everything right.” The feedback from physicians so far has been great, he adds. “We’re getting very positive comments especially on the stability of the catheters. The irrigated gold tip considerably increases the safety of the procedure.” Mr. Gellhaus emphasises that quality is at the core of everything Biotronik does. The company’s philosophy based on ‘excellence for life’, and within that framework they plan to continue to focus on creating the most advanced patient management solutions in the areas of heart failure and atrial fibrillation. In Cardiac Rhythm Management, the upcoming release of the newest generation of Biotronik Home Monitoring® further reinforces the company’s pioneering position in telecardiology. The high quality cuttingedge bradycardia portfolio still includes the unique Closed Loop Stimulation® (CLS). Their various devices for cardiac resynchronization therapy meanwhile include the recently launched Lumax 540 HF-T, with the innovative Heart Failure Monitor® to predict potentially worsening heart failure status ahead of time. The implantable devices are complemented by a broad range of leads that are designed to provide bestin- class performance. Biotronik has also significantly expanded their clinical research program with four major landmark trials, of which CASTLE-AF and EchoCRT, are particularly noteworthy. These two studies, collectively enrolling more than 1600 patients and with mortality and morbidity endpoints that aim to appreciably expand treatment indications, could significantly change the therapy paradigm for both atrial fibrillation and heart failure respectively. Biotronik is definitely on the move and is one the fastest growing medical device company globally. The company operates a global network. About 4,500 employees research, develop, produce and sell Biotronik products, and support customers on every continent. Mr. Gellhaus adds that strong growth for the company is planned to continue in the years ahead as the heart failure and atrial fibrillation businesses develop. top - home