New Wave Surgical Receives FDA 510k Approval for D-HELP™ and DELP™ NEW YORK, NY, Oct. 4, 2006 /Medical Device News/

New Wave Surgical Corporation announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its proprietary D-HELP and DELP laparoscopic surgical devices. D-HELP, short for Defogging Heated Endoscopic Lens Protector, is a multifunctional disposable device designed to eliminate fogging, improve visualization, increase efficiency, and reduce safety hazards in any laparoscopic procedure. The device heats an internal reservoir of anti-fog solution above body temperature in under a minute and stays heated for over five hours, offering surgeons a convenient and reliable way to defog the laparoscope throughout the entire procedure. D-HELP is fitted with a microfiber surface for cleaning the lens, a special True-White™ target at the base of the reservoir for white balancing the laparoscope, and a shock-absorbing foam shell to protect the laparoscopic lens from damage. By bathing the lens in liquid when the laparoscope is not inside the body, the device eliminates fire hazards resulting from the fiberoptic light while also safely secureing the laparoscope to the surgical field. DELP, short for Defogging Endoscopic Lens Protector, is a smaller non-heated version of D-HELP for use in any endoscopic procedure. These shorter endoscopic cases, including arthroscopies, cystoscopies, bronchoscopies, and colonoscopies, do not always require heat to defog the lens, but they can still benefit from the anti-fog solution, microfiber cleaning, lens protection, white balancing, and fire safety provided by DELP. D-HELP and DELP, along with the patent-pending MicroPad™ surgical sponge, are the first of New Wave Surgical’s Intra-Procedure Endoscopic Care™ devices. New Wave Surgical CEO, Alex Gomez, commented, "This is a significant step in the Company's execution of its business plan and lays the groundwork for the development of the rest of our line of intra-procedure endoscopic care devices. As patients and doctors have become more knowledgeable about the benefits of minimally invasive surgery, the laparoscopic and endoscopic markets have experienced enormous growth. These new procedures, however, have problems that are not yet addressed by the conventional surgical accessories. D-HELP and DELP finally bring new solutions to the surgeon, patient, hospital staff and hospital administration, and all in a single inexpensive device."

ABOUT NEW WAVE SURGICAL CORP. New Wave Surgical Corp. is a medical device development company incorporated in 2003 to design, patent, and market medical devices for the laparoscopic and endoscopic surgical markets. Four devices have been developed, and capabilities have been established for manufacturing, packaging, sterilizing and shipping the products. The development of the devices was accomplished with the participation of leading surgeons, surgical residents, and operating room staff. New Wave Surgical’s medical devices are sterile intra-procedure disposable units that all complement each other to provide a complete solution for the entire endoscopic market For more information on New Wave Surgical, visit www.newwavesurgical.com