The way in which company fortunes can be impacted by the pace of FDA regulatory approval was demonstrated last month, with a major delay. Ophthalmic product maker Staar Surgical (Monrovia, California) in February said that federal regulators are unlikely to approve its new implantable lens this year, as it had hoped. After meeting with FDA officials to discuss its premarket application supplement (PMA-S), Staar said it learned that its Visian TICL (toric implantable Collamer lens) would have to be reviewed by the Ophthalmic Devices Panel of the Center for Devices and Radiological Health because the device is the first toric phakic implantable lens to be reviewed.

The Visian TICL is designed to treat myopia and astigmatism. The company submitted the application last May as a supplement to the PMA application for its Myopic Visian ICL, which the FDA approved in December 2005 for the correction of myopia in adults.

David Bailey, president/CEO of Staar, said it is “highly unusual for a supplemental application to be submitted to the panel for review.” He said that “the TICL is a first-of-its-kind device and we look forward to providing all necessary support to substantiate its safety and effectiveness.”

Bailey added: “We had hoped for faster review, but based on this feedback we believe that approval of the TICL will be unlikely in 2007, as previously anticipated.”

The Visian TICL — which is already on the market in Europe and some Asian countries for the correction of astigmatism — is a refractive phakic implant intended for placement in the posterior chamber of the eye. Astigmatism, which is usually caused by uneven curvature of the surface of the eye, causes light rays to focus at different points inside the eye. A person with astigmatism will experience blurriness in part of the visual field in both near and distance vision. The supplemental filing supports an indication for the correction of myopia and astigmatism in adults with myopia ranging from -3.0 to less than or equal to -20.0 diopters with astigmatism ranging from 1 diopter to 4 diopters at the spectacle plane, with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation.

The device was approved in China last August. Soon after receiving approval there, Professor Yuangui Wang performed the first two bilateral surgeries on Aug. 9 at the WJ Army Hospital (Shenzhen, China). The first patient was a nearsighted 35-year-old male journalist with astigmatism, and the second was a severely nearsighted 19-year-old female student, also suffering from astigmatism. Staar said both had “significantly improved vision” after the procedure. The company also reported that after the Visian ICL was implanted, the first patient could see 20/15 with both eyes and the second patient improved to 20/20 the following day.

Made of Staar’s biocompatible Collamer material, the ICL is the only minimally invasive foldable lens of its kind approved for the Chinese commercial market. As a result of the foldable design, the ICL procedure allows an incision up to 50% smaller than competing technology, Staar said, adding that its placement in the eye behind the iris “provides a more aesthetically pleasing outcome.”

Staar’s minimally invasive ophthalmic products include products designed to improve patient outcomes for cataracts and glaucoma.


MedicAlert’s RFID technologyin pilot test using studenthealth records

MedicAlert (Turlock, California), a provider of emergency information services and personal health records, said that it will launch a pilot project to test the use of radio frequency identification detection (RFID) in improving access to student health information.

MedicAlert is working with Advanced Micro Devices (AMD; Sunnyvale, California), Siemens IT Solutions and Services (Munich, Germany) and California State University, (Stanislaus, California) to demonstrate the application and use of RFID technology. The 90-day pilot was expected to start March 1, with an estimated 200 students will participating.

Paul Kortschak, president/CEO of MedicAlert Foundation, said, “Medical personnel will have access to electronic health information that could save a student’s life.”

He credited funding from AMD “that enables us to innovate our life-saving services using new technologies.”

Paul Maier, senior VP of sales at Siemens IT Solutions, said, “With our extensive background in RFID and experience in developing innovative solutions, we are delighted to take the next step with MedicAlert in improving process, safety and efficiency.”

Students participating in the trial will be provided with a one-year free subscription to MedicAlert Membership and a plastic RFID-enabled ID Card. The RFID circuit on the card will only contain the student’s unique member identification number linked to a personal health record securely stored at the MedicAlert repository.

Each time a student enters the student health center, a secure kiosk will print out a Personal Health Summary Record of the student’s medical information that has been stored in the MedicAlert repository. The summary can then be added to the “face sheet” or to the student’s medical record to be used as additional or supplemental information for the clinical visit.

MedicAlert services are built around a repository of health information that enables members to manage their personal health records while maintaining confidentiality.

AMD is a provider of microprocessor solutions for computing, communications and consumer electronics markets. Siemens IT Solutions and Services —launched in January by Siemens — offers services ranging from consulting to management of IT infrastructures.


Eastman Kodak's spun-off Health Group now Carestream Health

Carestream Health is the new name unveiled for the independent company that will result from the sale of the Health Group of Eastman Kodak (Rochester, New York) to a subsidiary of Onex (Toronto). The $2.55 billion sale is expected to close in the first half of '07, subject to regulatory approvals. The deal was first disclosed .

Carestream will become a stand-alone company, "taking its place among the world's largest medical imaging and healthcare IT businesses," Kodak said.

The Health Group "now takes a major step toward a new beginning" with introduction of the new name, said Robert Le Blanc, chairman of Carestream and managing director of Onex.

Kodak said the name will vary somewhat internationally to reflect local laws and practices. In the UK, for example, it will be known as Carestream Health UK Limited, and in some countries -- Argentina, Brazil, China and Mexico -- the Carestream Health name will not be used initially for regulatory reasons. Onex said no change will occur worldwide in the use of Carestream as a sub-brand for products and services.

The Health Group is a provider of medical and dental imaging systems and information technology solutions, molecular imaging systems and other testing products.


Theragenics’ campaign‘back in the saddle’

Theragenics (Atlanta), a medical device company serving the prostate cancer and surgical markets, reported its return to the sport of professional bull riding to promote its prostate cancer treatment awareness campaign. Professional bull rider Greg Potter will serve as the campaign’s spokesman, educating men with the campaign’s simple message, “Know your options for prostate cancer treatment.”

The campaign was launched in tandem with the 2007 Professional Bull Riders (PBR) Built Ford Tough Series tour, which kicked off in New York City in January at Madison Square Garden.

“In 2005 we became the first cancer treatment company to sponsor the PBR,” said M. Christine Jacobs, president/CEO of Theragenics. “The general appeal of the PBR allowed us to effectively message to men, and the success of that campaign exceeded our expectations. With the addition of Greg Potter, we look forward to building on the momentum we created two years ago.”

As a result of the company’s awareness efforts, calls to the TheraSeed Prostate Cancer Information Center increased by up to 2,000% over typical volumes in the broadcast markets and TheraSeed sales increased in most of the targeted markets, the company said.


Tyco Healthcare to be named Covidien

Tyco Healthcare (Mansfield, Massachusetts) said that its new name will be Covidien, once the global healthcare company separates from parent Tyco International (Pembroke, Bermuda) this spring and becomes an independent, publicly traded company.

“Covidien . . . marks the start of an exciting new chapter for us,” said Richard Meelia, president/CEO, of Tyco Healthcare. “The name reflects our corporate goal to build and strengthen our role as an integral healthcare partner, supporting the lifesaving work of medical professionals.”

Tyco Healthcare manufactures medical products, including disposable medical supplies, monitoring equipment and medical instruments.