Millions of people experience heart rhythm disturbances in their lifetime. This has propelled cardiac electrophysiology to become one of the most innovative fields in medicine today. BIOTRONIK, a privately owned, global company with headquarters in Germany, is one of the leaders in the cardiac rhythm management space. Aside from its European roots, the company has an increasingly global market and expanding US presence. Within the last ten years BIOTRONIK has managed to take a great portion of the American market share. The company continues to innovate and develop new cardio- and endovascular technology that aims to optimize patients’ healthcare and quality of life. We at Medgadget sat down with Rupa Basu, Senior Vice President of Marketing, Corporate Accounts and Strategy at BIOTRONIK, Inc. during Heart Rhythm 2017 conference in Chicago to learn more about BIOTRONIK’s new technologies and devices.
Kenan Raddawi, MD, Medgadget: BIOTRONIK recently received FDA approval for a number of products and technologies. Can you please tell us more about BIOTRONIK’s newly FDA approved technologies and recently launched devices?
Rupa Basu: About a month ago we launched Plexa ProMRI, the smallest MRI compatible defibrillator lead in the United States. It is a 7.8 French (F) lead. Our competitors’ leads range between 8.1-8.2 F. What is unique about Plexa is the helical design, which adds extra durability and improves handling.
The other lead that we just launched, and actually extends our heart failure portfolio, is the Sentus QP lead. This lead is unique with its isodiametric design. In other words, the electrodes on the lead have the exact same diameter as the rest of the lead and do not protrude out. This gives the users an advantage in reducing friction and improving maneuverability. Physicians involved with our clinical studies reported that the lead tracked very well. Sentus is our first Quadripolar lead. It is a very important addition to our company, as it completes our heart failure solution system. Today, we have Sentus – a Quadripolar lead – and Inventra HF-T – the highest energy generator Implantable Cardioverter Defibrillator (ICD) with 42 joules (J) per shock. This is the highest amount [of joules per shock] among all of our competitors.
We also received FDA approval for BIOTRONIK’s MultiPole Pacing (MPP) technology, which is available on our new Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems. MPP provides heart failure patients, who are non-responsive to CRT, a new treatment option by permitting the left ventricle to be paced twice per cardiac cycle.
Another technology that we just launched in the US is MRI AutoDetect. We realized even though its great to have MRI compatible devices, there was an increased burden on healthcare providers when it came to performing MRIs. Prior to the availability of our MRI AutoDetect technology, CRM device patients who needed an MRI scan would have to connect with their cardiologist first. Then, the physician would need to work with the patient, the MRI center and the industry representative to figure out a time to send a technician to the MRI facility to program the device in and out of the MRI mode. With MRI AutoDetect, you do not need to do all of that. When the patient knows they need an MRI scan, they set up a visit with their physician to activate the sensor in the heart rhythm device. Then, they have a two-week window to have their MRI done without the need of an industry representative to be present at the MRI center. The device automatically detects when the device is in an MRI magnetic field, and switches itself to an MRI mode while the patient gets the scan. Within a minute after the scan, the device switches back to the regular mode and then transmits a message to the patient’s physician that the device has switched back to its normal mode.
Medgadget: Regarding MRI AutoDetect, why does the physician need to activate the sensor? And why is there only a two-week window to get the scan?
Rupa Basu: BIOTRONIK determined that a two-week window was sufficient to allow for rescheduling while providing flexibility for the patient. We then discussed this timeframe with FDA. If necessary, the physician can program a shorter timeframe.
Medgadget: Does BIOTRONIK have a patent for this technology, or should we expect to see more companies incorporate this technology into their devices?
Rupa Basu: Yes, BIOTRONIK has patented this technology. Now, I do not know what the other companies are working on, but you will not see the exact same technology from our competitors.
Medgadget: During HRS Sessions, we have heard a lot of talk on leadless pacing. Two of your main competitors, Medtronic and Abbott/St. Jude, have already launched leadless pacemakers. Will BIOTRONIK join this race? If so, when?
Rupa Basu: Every company is working on it. I cannot share details where we are right now. We are a private company, so we do not need to worry about shareholders wanting that information. But yes, every company is working on this platform. The key with leadless pacemakers is reliability and patient safety. We at BIOTRONIK take our time to make sure that when we launch any product, it is something that we can stand by.
Medgadget: Does BIOTRONIK believe leadless pacemakers are the future of cardiac pacing?
Rupa Basu: When you look at the cost associated with leadless pacemakers and the technology available today in single chamber pacemakers, it is clear that leadless pacemakers are still too early in the stage of development to fully replace pacemakers with leads. The technology would have to continue to develop, and the industry would need to come up with a device that is dual chamber or biventricular that is also cost effective, yet can be implanted safely. It is too early to tell.
Medgadget: How can BIOTRONIK keep an edge in this highly competitive industry and tight market?
Rupa Basu: It goes back to our core focus on durability, reliability and safety. We are the only company that has never had a lead recall. We take pride in that. Safety is the number one focus of our company. While our competitors have moved to manufacturing in countries where there is lower cost of labor, we have taken a different approach. Our focus has really been on moving more towards automated manufacturing. We believe if we can have fewer human hands interfering with the manufacturing of our products, we can reduce the number of human errors. If you were to see our manufacturing plants versus our competitors’, there is a huge difference. Our products have proven time and time again to work as designed with long-term reliability.