FDA Clears Biolase Soft Tissue Diode Laser For Broad Surgical Indications

In short

Dental laser specialist Biolase, Inc. , has seen its EPIC 10S™ soft tissue diode laser cleared by the U.S. FDA for use as a surgical instrument for over 80 different indications in 19 medical markets, from ENT to Vascular surgery. The EPIC 10S is the surgical model of the recently released, next-generation dental EPIC 10™.

Background

Biolase, Inc. develops, manufactures and markets dental lasers and also distributes and markets dental imaging equipment. Its diode lasers are currently used in dentistry for a wide variety of surgical soft tissue procedures as an alternative to invasive and traumatic conventional devices, such as the high-speed drill, scalpel, or electrosurge.

Crossing the divide into surgical applications for its laser technology makes total sense when one looks at the vast number of indications for which the technology has now been approved. For the full list, refer to the company’s press release here. Examples range from hemostasis, incision, excision, ablation, and vaporization of tissues from the ear, nose, throat and adjacent areas, through to arthroscopic use in chondromalacia, adhesiology and tumour resection.

 

The 940nm laser wavelength of the EPIC 10 platform is better absorbed by hemoglobin (Hb) and oxyhemoglobin (HbO2) than other diode laser wavelengths, so it cuts efficiently at low power and with considerably less heat and discomfort, making it an excellent alternative to conventional surgical devices.

The device uses disposable tips which help reduce the risk of infection and cross contamination.

Company comments

Federico Pignatelli, Biolase’s Chairman and Chief Executive Officer said; “This clearance gives us the ability to leverage our EPIC 10™ modular soft tissue diode laser platform and consumable business across a wide range of multi-billion dollar medical markets with appropriate strategic partners or in a direct mode. With the vast number of procedures now available for the EPIC, the opportunities for this new modular platform are tremendous.”

“It is truly remarkable to see how our core technologies can impact so many other medical fields. Our 940nm diode lasers are excellent alternatives to conventional surgical devices and we have already begun performing clinical studies for a variety of these new applications and some of our early results have been extraordinary,” said Fred Furry, Chief Operating Officer and Chief Financial Officer.

Source: Biolase, Inc., Marketwired