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Nika · #1 (**permalink**) 04-24-2005, 10:04 PM

Source:
PR Newswire

4/6/2005

CUPERTINO, Calif., April 6 /PRNewswire/ -- Novare Surgical Systems Inc., today announced that it has received clearance from the U.S. Food and Drug Administration to market its family of EndoLink surgical instruments, the first single-use hand-held instruments to incorporate six degrees of articulating freedom. Comprised of grasper, dissector, needle drive and scissors, the instruments are used in laparoscopic surgery to enable minimally invasive approaches in gastric bypass, cardiac bypass, pulmonary lobectomy and other general and urologic procedures.

According to Kerry Pope, Novare's president and chief executive officer, the EndoLink system offers the surgeon enhanced anatomical access and device control not available with traditional straight laparoscopic instruments. "Our novel system can be incorporated into instruments as small as 3 millimeters and enable articulation similar to a human wrist. This gives the surgeon greater control and access that can provide important gains in minimally invasive surgery."

EndoLink

Unlike traditional endoscopic instruments that feature four degrees of freedom -- up/down, left/right, rotation, and in/out actuation, the EndoLink instruments also feature the ability to move the wrist left/right and up/down. The additional two degrees of freedom enables a whole new class of minimally invasive procedures, and can significantly reduce the complexity and shorten the learning curve of a number of existing high-volume minimally invasive procedures.

Roger A. de la Torre, M.D., co-director of bariatric services at University of Missouri, Columbia said, "The EndoLink system can eliminate challenges often experienced in complex laparoscopic surgical procedures, such as suturing and knot-tying. The ability to articulate the grasper so that it presents at a 60-to-90 degree angle makes looping the suture a simple task, and can reduce the level of complexity for many general surgical procedures."

"The EndoLink places the surgeon's wrist inside the chest," explains William Mayfield, M.D., thoracic surgeon at Piedmont Hospital in Atlanta. "Instruments that incorporate the EndoLink system are easy to use, intuitive, scalable, and allow the surgeon to perform endoscopically-directed maneuvers that he or she could never perform before with conventional instruments. EndoLink represents a new platform of instrumentation for endoscopic and minimally invasive surgery."

Billy Cohn, M.D., director of minimally invasive surgical technology at Texas Heart Institute, Houston, added, "These fully-articulating instruments have the potential to revolutionize limited access cardiac surgery. The increased range of motion provided by the EndoLink mechanism may indeed prove to be the missing link cardiac surgeons have been searching for in our quest to develop closed-chest cardiac surgical procedures. By combining this technology with current videoscopic visualization, new approaches for treating valve disease, cardiac rhythm disturbances, and other heart disease will naturally evolve. It is a very exciting development for our field."

About Novare Surgical Systems

Based in Cupertino, Calif., Novare Surgical Systems Inc. was founded in 1999 to develop, manufacture and market proprietary devices for minimally invasive and traditional surgical procedures. The company has commercialized the Intrack(R) family of atraumatic occlusion devices, which includes the Engage(R), Cygnet(R), Novaclip(R) and Greyhound(R) product lines. Enclose(R), an assist device for multiple proximal anastomoses in coronary artery bypass graft (CABG) surgery, was introduced in 2002. For more information, visit the company's web site at http://www.novaresurgical.com/ .

CONTACT: Kerry Pope, President & CEO, of Novare Surgical Systems Inc., +1-408-350-9912, or kpope@novaresurgical.com; or Charles Versaggi, Ph.D., of Versaggi Biocommunications, +1-415-397-3087, or cv@versaggibio.com, for Novare Surgical Systems Inc.

Web site: http://www.novaresurgical.com/

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FDA Clears Novare's EndoLink(TM) Articulating Instruments for Marketing; Six Degrees