Tiotronik’s Renamic Neo communicates with a medical device implanted in a patient, such as a pacemaker, ICD, or implantable cardiac monitor. The control unit received FDA premarket approval in April 2022. The privately owned medtech company has been developing medical devices that improve the quality of life of patients suffering from cardiovascular and endovascular diseases for more than 50 years.
According to Biotronik, the Renamic Neo programmer offers complete connectivity and a long battery runtime to enable mobile use and workflow flexibility. Due to its compact design, onboard PSA, SafeSync telemetry, and integrated compartments, the device is designed to be convenient to handle during clinical practice.
It offers complete wireless connectivity plus Ethernet and USB, and it includes the company’s ReportShare and EHR export for paperless environment and remote consultation. The device is significantly lighter and smaller than its predecessor. The battery-powered device features a 12-in. LCD touchscreen display, a built-in analyzer, and several connectivity options.
In addition to Ethernet and USB interfaces, Renamic Neo connects wirelessly to the Internet via cellular networks or Wi-Fi, providing various data export functions. The state-of-the-art features give users freedom to export programmer data to the hospital electronic health record (EHR) system or digitally share the device interrogation report for remote medical consultation.
Renamic Neo offers LiveSupport, which allows clinicians to share the programmer screen with, or grant programmer control to, Biotronik technical support personnel at remote locations. The control unit allows the physician or patient to read out information such as battery status, heart rate, and other parameters important to the functioning of the implanted device. In developing this application, guidance from Schurter Electronics played an important role.
The Renamic Neo is the world’s first device that can read and program the implant completely wirelessly, which requires low electromagnetic radiation. Communication between the Renamic Neo and the implanted device takes place wirelessly, via a low-power radio signal. It is essential that there is no interference in the frequency range of this signal. When developing the application, electromagnetic compatibility (EMC) was therefore an important issue from the start.
Testing for Safety
In a special emission-free EMC chamber at Biotronik, Schurter tested a number of controller types to see which solution provided the lowest emission. Other components, such as the LCD display, was also tested and optimized. With these results, Schurter developed prototypes with the best-performing components. The prototype components were then also tested at Biotronik.
When the Renamic Neo went into production, Biotronik asked Schurter to include an EMC test as standard in the production process. This enabled Biotronik to officially measure and confirm that their products met the medical EMC standard, EN 60601-1-2. The device was tested in a shielded cabinet, where no radiation could penetrate from the outside. The product was placed in the cabinet, connected with cabling, and switched on. An antenna in the cabinet captured all signals around the frequency in question, and those went through a coax cable to a spectrum analyzer outside the cabinet, which measures the signals.
An algorithm determined an average value for these signals, which must lie between 3 and 20 dB. Based on the requirements set by Biotronik, Schurter redesigned the entire printed circuit board to minimize exposure to emissions. Schurter manufactures and distributes components for circuit protection as well as connectors, switches, EMC products, and customer specific components.
The Renamic Neo has now been in production for two years. Schurter is currently supplying pre-series quantities, with a volume goal to product a few thousand per year. Schurter is currently fine-tuning the production process, where it is initially focusing on the cost structure. Future areas for optimization will include the following:
Making improvements in production technology.
Modifying materials or production methods to reduce costs.
Biotronik has already reduced production costs by more than 20 percent per unit over the last two years. The continuous optimization of materials and production processes is ongoing.