Hologic Contraceptive Device Gets Nod From FDA Panel

12/14/07

Bedford, MA-based Hologic’s $6.2 billion union with Cytyc, completed in October, seems set to bear fruit. The newly merged company, now one of Massachusetts’ largest life sciences concerns, announced today that an FDA panel has recommended that its permanent contraception device, Adiana, be approved. The device—which offers a minimally invasive alternative to tubal ligation—is an asset Cytyc had obtained this spring through the acquisition of a privately held California company.

The news of the approval recommendation comes as a bit of a surprise, as yesterday the FDA advisory panel had expressed some concerns about how well Adiana prevents pregnancy. (The FDA is not bound to follow its panels’ recommendations, but it usually does.) In a press release, Hologic (NASDAQ: HOLX) said that the device had an efficacy rate of 98.9 percent over the course of a year in a study of 645 women. The panel recommended that approval of the device be contingent upon further follow-up of those patients, additional studies, more specific labeling, and other conditions.

Traditional tubal ligation, or “getting your tubes tied,” is the most common form of contraception worldwide and usually involves general anesthesia and abdominal incisions. With Hologic’s approach, doctors thread a catheter through the vagina and into the fallopian tube; the catheter first removes the inner layer of cells using low-level radiofrequency energy, then deploys a tiny polymer plug. The procedure only requires local anesthesia and takes about 15 minutes; new tissue grows into the polymer to block the tube permanently.

If approved, Hologic’s device will compete with another catheter-deployed device, Essure, which is marketed by Mountain View, CA’s Conceptus and was approved in 2002.

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