BIOLASE receives FDA approval for Waterlase use in apicoectomy surgery
BIOLASE Technology, Inc., a medical technology company focused on pain-free medical and dental procedures, today announced that it has received clearance from the Food and Drug Administration for the patented Waterlase® system for use in apicoectomy surgery. Apicoectomy surgery, a treatment for root canal infections and complications, includes cutting gum flaps, bone and the apex of the tooth to access the infected area. For more information on apicoectomy surgery, go to www.biolase.com.
Malcolm Zola, DDS, Chief, Oral Surgery and Maxillofacial Surgery, St. Barnabas Hospital, New York City, commented, "Use of the Waterlase for apicoectomies is a very significant development in dentistry. Benefits while performing the procedure with the Waterlase, compared to traditional methods, include less bleeding, less trauma, more precision, smoother cuts, more control and superior visibility. Post-operative benefits include reducing or eliminating post-operative pain, inflammation and reducing or eliminating the need for post-op pain medications.
"When using a drill in apicoectomy surgery, adjacent nerves, roots and bone tissues can be damaged. With the Waterlase, we experienced no damage to adjacent tissues. It was easy to use in narrow spaces, caused no charring or burning and we did not have to change surgical tools several times."
Dr. Zola continued, "I expect these important clinical benefits to cause a paradigm shift for both dentists and patients. As the public becomes more aware of the benefits of Waterlase procedures, they will begin demanding them and dentists will now be able to provide them."
Dr. Zola is Board Certified in Oral and Maxillofacial Surgery, and was formerly chairman of Oral Surgery at NOVA Southeastern University, College of Dentistry, Florida.
Dan McEowen, DDS, Frederick, Maryland, with over 20 years of dental surgical experience, commented, "Surgical procedures performed with the Waterlase represent a major advancement for both dentists and patients. This clearance for doing flaps reaches far beyond just apicoectomy surgery. Flap surgery is very common for numerous surgical procedures, including periodontal procedures, implant placement and recovery, extracting wisdom teeth, exposure of impacted teeth for orthodontics, ridge augmentation, access to the bone and more. All of these procedures will benefit from the reduced trauma, pain and improved comfort for the patient both during the procedure and post-operatively."
Jeffrey W. Jones, President and CEO of BIOLASE, noted, "This new clearance, another first in the dental industry, combined with clearances last year for complete root canal and bone procedures, further demonstrates the clinical importance of Waterlase YSGG technology. It makes the Waterlase even more appealing to specialists, such as endodontists, oral surgeons and periodontists as well as general dentists. They can now perform a very wide range of procedures with the Waterlase, from general restorative, all classes of cavity preparations, numerous soft tissue procedures, complete laser root canals, bone and now apicoectomies. This continuing dedication to clinical advancements, research and development will only strengthen our already dominant position in a rapidly expanding market."
