The advances in medical devices for monitoring, surgery and R&D have made cardiac care one of the most exciting and successful areas for the proliferation of medical gadgets. Let's take a look at two such devices that are changing the world of cardiac care.
In the early days of implantable cardioverter defibrillators (ICDs), patients were told they could not have an MRI, and to stay away from microwaves, store detection scanners, airport scanners and so on. MRI-compatible devices have available been available for years, but up until now the existing devices had to be reprogrammed just before the exam and reset back following the scan.
Biotronik has introduced AutoDetect technology, which allows a cardiologist to schedule an MRI and preprogram the device at the same time. The preprogramming process allows for a two-week window for the MRI to be performed. The unique process allows the device to detect it is inside an MRI machine and automatically switch to its MRI-safe mode. Immediately following the scan, the device goes back to working as before.
The implant also sends a report to the cardiologist as soon as it connects to the patient's Biotronik Home Monitoring station. Because the implant stays in this MRI-compatible mode only during the scanning period and returns to its previous working therapy mode, it enables the quickest and safest protection to the patients. Biotronik's Ilivia ICD and CRT-D implants feature the firm's ProMRI and MRI AutoDetect technologies and have been approved for use in Europe.
Paroxysmal atrial fibrillation often requires cardiac ablation when drugs are not able to treat the AF effectively. Until recently, cardiac ablation catheters have had to rely on X-rays or cardiac mapping to guide the process.
CardioFocus, a company located in Massachusetts, has received premarket approval from the FDA for a device called the HeartLight System. The system provides "light" for a direct visual of the area where the ablation is to occur. The device combines a balloon at one end and an optical fiber that delivers laser energy into the heart. A separate light is used to position the device which allows the physician to visualize the area under the laser.
A randomized, controlled study that included 353 patients in 19 leading cardiac arrhythmia centers in the U.S. led to the approval. Researchers showed that with a single ablation procedure the majority of the patients were still AF-free after 12 months.
AF is the most common cardiac arrhythmia, affecting more than 33 million people worldwide, and an estimated 2.7-6.1 million people in the United States alone. Catheter-based treatment of AF has created a market in excess of $1.5 billion, currently growing at approximately 15 percent annually, making it one of the largest- and highest-growth medical device market opportunities.
