Contraception device maker Conceptus Inc. (CPTS) recently announced that the US Food and Drug Administration (FDA) approved the removal of nickel hypersensitivity contraindication from the Essure procedure Instructions for Use (IFU).
Conceptus expects this endorsement to further boost the sale of the company’s non-surgical permanent birth control procedure, Essure, by expanding the number of potential patients eligible for the method.
The FDA voted in favor of Conceptus after observing case histories for over a decade and delving into data garnered from the Essure clinical trials that demonstrate no causal relationship between nickel sensitivity and wearing the Essure micro-insert.
Conceptus derives a major share of its revenues from Essure. However, during the second quarter of fiscal 2011, domestic sales of Essure slipped 11.4% year over year to $24.8 million impacted by lower patient visits to OB/GYN offices and ongoing competitive product trialing.
The company in a counteractive move is expanding its sales coverage and is gradually achieving success in reducing the impact of competition, particularly from physicians trialing other competing products. The recent FDA label decision will further help Conceptus to gain traction in its domestic business.
Moreover, sales of the Essure system also depend on the number of physicians trained to perform the procedure. Conceptus is working to make the system available worldwide by raising consumer and physician awareness as well as imparting training to physicians on performing the procedure.
During the recently reported quarter, the company expanded its physician penetration by enrolling 538 new physicians into preceptorship, certifying approximately 290 physicians and transitioning approximately 110 physicians to performing procedures in the office setting. Till date, around 13,553 physicians are fully equipped to perform the Essure procedure.
As the first permanent birth control method, the Essure procedure received the FDA approval in 2002. Conceptus claims this to be 99.95% effective based on one year of follow up. Essure procedure is covered by most insurance plans and is a cost effective method with minimum hazard. Since 2002, 550,000 women worldwide have undergone the Essure procedure.
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