Conceptus (Mountain View, California), maker of the Essure procedure a non-incisional permanent birth control method reported that Medi-Cal, California's fee-for-service Medicaid program, is now covering the procedure.
The company said low-income or disabled women in California now have a safe and effective permanent female birth control option that does not require the general anesthesia, incisions or long recovery period of traditional tubal ligation.
"We are [pleased] that Medi-Cal has completed its review of the safety and efficacy of the Essure device and has established coverage for this procedure," said California Assembly Speaker Pro Tem Sally Lieber. "This is a great day for the women of California covered by Medicaid, who will now be able to avoid the risks and long recovery times associated with traditional tubal ligation surgery."
The Essure procedure, approved by FDA in 2002, is a permanent birth control procedure that replaces tubal ligation for women. In the comfort of a physician's office and in about 10 minutes, the soft micro-inserts are placed into the fallopian tubes through the cervix, eliminating the need for incisions. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tubes.
World Heart receives Nasdaq letter
World Heart (Oakland, California) said it has received a Nasdaq staff determination letter stating that the company's requests for continued listing on the Nasdaq Capital Market have been denied.
The exchange noted that the company did not provide a definitive plan evidencing its ability to achieve near-term compliance with the continued-listing requirements or sustain such compliance over an extended period of time, as required by Marketplace Rule 4310(c)(4) and Marketplace Rule 4310(c)(3), which requires the company to have a minimum of $2.5 million in stockholders' equity or $35 million market value of listed securities or $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years.
Accordingly, unless the company requests an appeal of this determination, trading of its common stock will be suspended at the opening of business on May 21, and a Form 25-NSE will be filed with the SEC, which will remove the company's securities from listing and registration on Nasdaq.
WorldHeart makes mechanical circulatory support systems.