August 21, 2014 — Corindus Vascular Robotics announced the results of a retrospective study comparing use of radiation and contrast for patients enrolled in its CorPath PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention) study to a matched traditional manual PCI (percutaneous coronary intervention) patient, published in the July 2014 issue of the Journal of Invasive Cardiology. Results of the study demonstrate the CorPath system provides significantly lower harmful radiation exposure to the patient when CorPath is used for the complete intervention.
“The study results support many of the key benefits of the CorPath system, including lower radiation exposure, fluoroscopy time and contrast volume, which benefit not only the interventional cardiologist but also the patient,” said David Handler, president and CEO of Corindus. “As the adoption of CorPath expands in cath labs across the country, we are motivated by the continued success of our customers who also believe in the need for improvement over current techniques and the benefits offered by CorPath.”
The paper, authored principally by Giora Weisz, M.D., chairman of cardiology, Shaare Zedek Medical Center, Jerusalem, compared the outcomes of 40 patients that underwent PCI procedures at a single site in the PRECISE trial using the CorPath robotic system to the 80 consecutive patients who met the same inclusion criteria but underwent conventional, manual PCIs at the same center.
Based on the research presented, the study demonstrates the CorPath can lower radiation, fluoroscopy and contrast versus a traditional, manual PCI. In the 38 cases in which the intervention was done exclusively with robotic-assistance, the findings revealed that robotic-enhanced PCI:
- Decreased radiation dose (1,347 ± 482 mGy vs 1,665 ± 1,026 mGy, P=0.04) for the patient and the operator;
- Decreased fluoroscopy time (9.3 ± 3.4 min vs. 12.3 ± 7.6 min, P=0.01); and
- Reduced contrast volume (119 ± 47 mL vs 137 ± 62 mL, P=0.07).
Corindus’ CorPath system is the first U.S. Food and Drug Administration (FDA)-cleared medical device to bring robotic-assisted precision and accuracy to coronary angioplasty procedures, traditionally performed manually by the interventional cardiologist. During a CorPath robotic angioplasty procedure, the interventional cardiologist sits in the radiation-shielded interventional cockpit, and advances stents and guidewires with millimeter-by-millimeter precision to physically open an artery blockage and help improve blood flow.
“Since completing the PRECISE study, Corindus has maintained a strong commitment to clinical research, as evidenced by our coordination of the ongoing PRECISION registry, also led by Dr. Weisz,” added Handler. “We are investing in such research programs to quantify the physician and patient benefits of the CorPath system, as well as investigate potential future indications such as peripheral, neurology and structural heart.”
For more information: www.corindus.com