Robotic Heart Surgery
The da Vinci system has probably most affectively influenced the Cardiac aspects of surgery. When dealing with heart surgery. It is very easy to make a costly or deadly mistake. These mistakes are reduced with the development of Minimally Invasive Surgery. The surgeon has a far better view with the da Vinci operating achine and can therefore distinguish between an artery and a vein. Also, in cardiac surgery, the use of robotic surgery is far more beneficial than traditional methods. The scarring is greatly reduced for the patient, thus the reduction of pain. Robotic Surgery also has helped in one of the fastest growing surgery’s, gastric bypass. This surgery has become increasingly safer since it’s introduction. Minimally invasive surgery has affected many forms of surgery, and is likely going to be used in more and more surgeries in the coming years.
A promising application for surgical robotics systems is minimally invasive mitral valve surgery, which is performed to treat narrowing or leakage of the valve. The traditional open procedure requires an extraordinarily high level of mechanical skill that now, with the marriage of telerobotic and surgical technologies, can be performed through tiny ports less than 1 cm long.
mid-December 2000, Intuitive Surgical received FDA approval to launch a
multicenter clinical trial evaluating the company's daVinci system for minimally
invasive mitral valve repair. The company stated that the trial will involve
recruitment of about 50 patients at six centers in the United States. The study
results should be available by the end of the year, according to Fred Moll, MD,
cofounder and medical director of Intuitive Surgical.
studies were conducted by the cardiac team at the University Health Systems of
Eastern Carolina/Brody School of Medicine at East Carolina University (ECU;
Greenville, NC). The multicenter trial will be led by W. Randolph Chitwood Jr.,
MD, chairman of the department of surgery at the ECU School of Medicine.
to a statement by Chitwood, "The patients in our feasibility study who had
their mitral valve repaired using this technology experienced much less pain and
trauma, better cosmetic results, and spent less time in the intensive care unit
and hospital compared with conventional mitral valve surgery where the patient's
breast bone is divided in half."
than 70,000 heart valve repair or replacement surgeries are performed annually
in the United States, notes Chitwood. "Although we are in the early stages
of developing and applying robotics to cardiac surgery, the future looks
in mid-December, Intuitive noted that the daVinci system received Category B-1
reimbursement designation from the Health Care Financing Administration,
allowing reimbursement for use of the system in FDA-approved clinical
Motion is also investigating mitral valve repair and replacement with its Zeus
system. The company has initiated a feasibility clinical trial for this
application, and is currently enrolling patients.
is expected that it will take about two to five years for robotic systems to be
approved for general cardiac use, according to researchers.
Regulatory Path for Device Makers
July 2000, FDA reclassified robotic surgical devices as Class II instead of
Class III products, making them eligible for the 510(k) clearance process
instead of the longer premarket approval (PMA) process.
manufacturers in the robotics industry were thrilled with FDA's decision.
"This reclassification was sweet music to our ears," says ISS's
Trivedi. "It greatly affects the timing of the market introduction of the
Robodoc system in the United States. Now, the biggest market in the world may be
accessible in a shorter period of time."
Motion's Wang echoes manufacturers' sentiments. "This decision was very
fortunate for us, and we feel it was the right decision. It shows that FDA
recognizes surgical robotics as next-generation, advanced surgical instruments
combined with already proven (less-invasive) technology."
Surgical's Moll hints that FDA's decision could let loose a stream of pent-up
creativity in the robotic surgery marketplace. "This decision was
appropriate," he notes. "FDA has gone through a process of determining
that these products are safe and efficacious–and now industry can move