Robotic Surgery and FDA Approvals

The da Vinci™ surgical system has been FDA approved to assist in urologic surgery, thoracoscopic (chest) surgery procedures, general surgery: general (digestive) laparoscopic procedures, gynecological laparoscopic procedures, coronary artery bypass surgery, mitral valve repair and cardiac revascularization.

In urologic procedures, the system is being used to perform radical prostatectomy, a minimally invasive radical prostate cancer surgery that profoundly reduces bleeding, pain, and recovery time. Intuitive Surgical noted that the da Vinci™ Surgical System has been successfully used in thousands of prostate cancer procedures world-wide.

In cardiac surgery, the system is being used to perform single or double vessel Beating Heart TECAB (Totally Endoscopic Coronary Artery Bypass), also called single or double vessel Beating Heart CABG (Coronary Artery Bypass Graft). This means surgeons currently perform single vessel or double vessel Coronary Artery Bypass Graft on patient's beating heart, with minimally invasive technique (closed-chest technique, keyhole surgery). In these cases, surgeons no longer need to crack patient's chest open (break patient's chestbones) and put patient's heart on the off-pump system to operate on an arrested heart (invasive, open-chest cardiac surgery).

History:
On July 11, 2000, Intuitive Surgical received clearance from the FDA to begin commercializing the da Vinci™ Surgical System in the United States for use in laparoscopic surgical procedures.

Additionally, on March 2, 2001, the manufacturer received its second FDA clearance for thoracoscopic procedures. And on May 30, 2001, the FDA cleared the da Vinci™ Surgical System for laparoscopic radical prostatectomy procedures.

On November 13, 2002, Intuitive Surgical's da Vinci™ surgical system received first FDA Cardiac Clearance for Mitral Valve Repair Cardiac Surgery.

On January 30, 2003, the FDA Clearance for Intracardiac Surgery now encompasses "ASD" Closure (Atrial Septal Defect Closure surgical procedure).

On July 8, 2004, Intuitive Surgical received clearance from the FDA for Cardiac Revascularization with the da Vinci™ surgical system.

On April 26, 2005, Intuitive Surgical received clearance from the FDA for Gynecological Laparoscopic procedures with the da Vinci™ Surgical System.

This makes the da Vinci™ Surgical System the only FDA-cleared, complete robotic surgical system commercially available in the United States for laparoscopic and thoracoscopic procedures.

*** Intuitive Surgical receives FDA Clearance for Gynecological Laparoscopic procedures:
=> read.

*** Intuitive Surgical receives FDA Clearance for Cardiac Revascularization:
=> read.

More about laparoscopic and thoracoscopic surgical procedures with the da Vinci™ surgical system:

=> IntuitiveSurgical.com
=> daVinciProstatectomy.com

Source:
=> MarketWire.com