Radiation exposure is a serious concern during fluoroscopic procedures like electrophysiology (EP) studies and radiofrequency catheter ablation of arrhythmias. Ablation is a definitive treatment in many patients compared over antiarrhythmic drugs. Ablation procedures require mobile catheters inside the cardiac chambers and vascular system to recognize the arrhythmia substrate prior to ablation. Proper catheter manipulation requires a skilled electrophysiologist working under fluoroscopic guidance. This may result in significant X-ray exposure, which is a risk for both patients and medical staff. Operators typically don lead aprons to protect themselves from radiation, but wearing lead can result in greater fatigue and orthopedic injury during long procedures. To overcome this problem, robotic catheter systems, controlled mechanically are introduced in the market.
Products in the market include Niobe, VDrive, Sensei X, Amigo RCS etc. Vdrive system consists of V-Sono ICE catheter manipulator and V-Loop variable loop catheter manipulator. Amigo was approved by the FDA for use in diagnostic EP studies of the right atrium and ventricle in 2012, with this indication later expanded in 2014 to include radiofrequency ablations. The research is ongoing to help accurately detect the catheter movements with the help of a laser mouse based master device. By laser sensor, the catheter’s position changes can be obtained.
The catheter manipulation devices are segmented based on indication, type of catheter and geography. On the basis of indication the devices are further sub-segmented into electrophysiology studies, Vascular Interventional Surgery and RF catheter ablation. Ablation process needs a special ablation catheter. Catheter ablation is most popularly used procedure for Arrhythmias, having a high success rate. EP studies are used either to diagnose arrhythmias or to assist in cardiac ablation procedures and hence will hold higher market share. This subsegment is expected to grow the fastest due to the increased establishment of EP labs every year in the United States. On the basis of types of catheter, the devices are segmented into, Intracardiac Echocardiography (ICE), ablation catheter and circular mapping catheter. The standard ICE catheter utilizes a linear array of crystals arranged longitudinally along the catheter to produce a fan-shaped image radiating coplanar to the long-axis of the catheter. Ablation catheter is adjusted to proper position by the operator, and the machine sends either RF waves, extremely cold temperatures, or laser light through it to make a scar, called ablation line. Manipulator for circular mapping catheter is responsible for advancement, retraction, rotation, tip deflection and loop size of the catheter. The circular mapping catheter manipulator is used to remotely control both the circular mapping catheter and the ablation catheter this lead to improved procedure outcomes, hence this is expected to gain market share over single ICE and ablation catheter manipulators.
Geographically the global market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. In 2014 North America accounted for the largest share of the market. Europe followed North America on account of revenue. Asia-Pacific market is expected to grow due to increasing aging population, improving and modernizing healthcare infrastructure, and high demand of electrophysiology devices, with special focus on countries like India, China and Japan.
A number of factors such as the development of technologically advanced catheter manipulation devices, increasing aging population with high risk of cardiovascular diseases, increasing incidence of arrhythmia cases across the globe, growing focus of key market players to expand their geographic presence, and growing demand of ablation procedures drives the growth of the global market.
Major players are Proven process medical devices, Sterotaxis, Inc., Hansen Medical, Catheter Precision Inc., Boston scientific, Biosense Webster etc.