RESEARCH TRIANGLE PARK, N.C., Nov. 4 /PRNewswire/ -- Quill Medical, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quill(TM) Barbed Polydioxanone Suture, for wound closure of dermal tissue. The product is the first in a series of tissue repair devices that the Company is developing. These products, based on Quill's patented technology, enable surgical sutures to "self-anchor" in tissue without the need of a suture knot.
This U.S. clearance follows last May's European marketing approval. Other products based on Quill Medical's patented suture technology have also recently been approved by the FDA for use as minimally-invasive devices for lifting skin in cosmetic surgery applications. The approval of the cosmetic surgery product was obtained in conjunction with its partner in the aesthetics field, Surgical Specialties Corp. of Reading, PA, and will be marketed under the name Contour Thread(TM).
"Surgeons worldwide use hundreds of millions of sutures each year to close wounds and repair tissue, all of which are secured with suture knots. The Quill(TM) self-anchoring suture eliminates painstaking and time consuming knot-tying, a benefit to nearly all surgeons and patients," said Matthew Megaro, Quill Medical President and CEO. He added, "This first product is for repair of skin and a range of similar products is being developed to address several other important surgical applications."
Amy Murtha, MD, Director of Obstetrics Research, and Michael Paglia, MD, Ph.D., both of Duke University Medical Center, Division of Maternal Fetal Medicine, led the clinical trial to demonstrate the performance of the Quill(TM) self-anchoring suture in closing the Caesarean section incision. The trial was conducted at Duke Medical Center, Durham Regional Hospital and Center for Women's Medicine in Greenville, SC. Over 40 OB/GYN physicians participated in the trial of 195 patients.
"There was a high level of enthusiasm for the barbed sutures from our surgeon investigators. All of our investigators went through a brief training program and found the suture to be easier and faster to use than conventional suture material," noted Dr. Murtha. "We believe that there will be many other applications that may benefit from the use of this self-anchoring suture technology," stated Dr. Paglia.
The Quill self-anchoring suture was invented by Gregory Ruff, M.D., Chairman of Quill Medical, Inc., who for 17 years was a member of the Department of Surgery of the Duke University Medical Center.
About Quill Medical, Inc.
Quill Medical, Inc. is a medical device company located in Research Triangle Park, North Carolina, which develops innovative surgical devices based on its novel and proprietary knot-less, self-anchoring suture technology. The company's products target diverse applications in the general surgery, orthopedic and aesthetics fields. The design, use and sale of the Company's products are covered by numerous issued and pending U.S. and foreign patent claims. For more information, visit http://www.quillmedical.com/ .
Quill Medical, Inc.