Bioceptive Inc. has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its suction cervical retractor as a new option for women and physicians undergoing a wide array of gynecological procedures. Bioceptive's new non-traumatic device uses gentle suction to engage the cervix, creating an easy portal into the uterus for a variety of instruments and procedures including endometrial biopsies, IUD insertion, fertility procedures and others. It replaces the standard cervical tenaculum forceps, which are used to pierce and clamp cervical tissue in order to stabilize the cervix and uterus.
This device will serve as Bioceptive's platform for its pipeline of products currently under development and in preclinical testing. While it can be used with numerous devices from other manufacturers, Bioceptive's patented system will also allow its future devices to pair with its cervical retractor to usher in a new era in intuitive, consistent, safe procedures for a variety of diagnostic and therapeutic procedures. One such device currently in preclinical testing is a comprehensive insertion system for intrauterine devices (IUDs) that replaces the four to five instruments currently used in IUD procedures.
David Turok, MD, MPH, Associate Professor of Obstetrics and Gynecology at the University of Utah, has worked with the company on ongoing development and clinical efforts. "Bioceptive's suction tenaculum is a truly novel gynecologic instrument that permits cervical traction without tissue penetration. This device coupled with Bioceptive's IUD inserter has the potential to revolutionize IUD insertion by dramatically simplifying the process," said Dr. Turok.
The company expects to begin a limited market rollout in late 2015.