Last month, the U.S. Food and Drug Administration called for better controls on medical radiation exposure. Patients undergoing diagnostic scans or medical treatments may be exposed to toxic levels of radiation, as may the physicians who treat them. Cath labs are known to be particularly hazardous when it comes to radiation exposure. Angioplasty, a procedure to treat narrowed arteries due to coronary disease, is performed in a cath lab using x-ray angiography imaging. Physicians who perform angioplasty can develop cancer or cataracts from radiation exposure. They may develop spinal problems or fatigue due to wearing heavy lead-protection garments and standing for long periods of time. This can translate to decreased quality of care for the patient. Angioplasty procedures are performed manually in a high-stress environment, and the potential for human error is considerable. In one market study, physicians self-reported that the stenting procedure had to be repeated in as many as 20 percent of patients due to inaccurate placement of the first stent.
Corindus Vascular Robotics has developed a robotic system to improve percutaneous coronary intervention (PCI) placement and reduce health risks to both the patient and the physician. The Natick, Mass.-based company designs, manufactures and commercializes precision vascular robotic systems for use in minimally invasive medical procedures. The company’s initial product, CorPath, is the world’s first system for the precise placement of coronary guidewires and stent/balloon systems in a cath lab.
CorPath consists of a single-use cassette containing PCI devices, which is placed at the patient’s bedside. The physician sits in a radiation-free cockpit nearby. Using touch screens and joystick controls, the physician can remotely guide the placement of the catheter or guidewires. The procedure takes less time than traditional angioplasty, so the patient is exposed to a lower dose of radiation. Remote operation of the PCI device could potentially reduce the probability of physician fatigue and human error. In a podium presentation last month at the CRT 2010 conference, a noted interventional cardiologist remarked that CorPath “can potentially raise the standard of care in PCI by improving standardization, reproducibility and accuracy” of stent placement.
Corindus plans to begin clinical trials of the CorPath system. The company’s technology may eventually be used in other areas of the vascular market, including more complex procedures such as structural heart repair.