A Medical Device Daily

Staar Surgical (Monrovia, California), a manufacturer of minimally invasive ophthalmic products, said that the first Visian ICLs (implantable collamer lenses) have been surgically implanted in China since the State Food and Drug Administration's recent approval of the product (Medical Device Daily, Aug. 7, 2006).

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.

Yuangui said, “After we implanted the Visian ICL, 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 highly 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.”

“The first successful procedures are an important achievement for Staar in our entry into the Chinese market,” said David Bailey, company president and CEO. “China is the second-largest market in the world for the LASIK procedure, and we feel we are taking the steps necessary to establish the Visian ICL as an attractive alternative to LASIK for the future.”

Staar's ICL is approved by the FDA for use in treating myopia, has received CE-marking and is approved for sale in 43 countries. More than 50,000 ICLs have been sold worldwide.

BD Vacutainer CD4 tube available in Africa

BD Diagnostics, a segment of BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) reported immediate availability in Africa of the BD Vacutainer CD4 Stabilization Blood Collection Tube.

The new device is designed to improve the accuracy of CD4 test results for HIV-infected patients and reduce healthcare costs associated with the CD4 testing process in the more remote areas of Africa, where blood specimens are often exposed to temperatures greater than 20 to 25 degrees Celsius.

The collection tubes currently used for CD4 testing limit post-collection transport time from two to three days or less, at storage conditions of only 20 to 25 degrees C. Testing laboratories often are required to repeat collection and testing of CD4 blood specimens due to these delayed or poor blood collection transport conditions, and substantial wasted costs are incurred by the labs.

The BD Vacutainer tube stabilizes CD4 cells for up to three days at 37 degrees C, and for up to seven days at 30 degrees C.

“By improving the reliability of HIV testing and the cost-effectiveness of laboratory practices, we move one step closer to our goal of increasing access to care for those HIV/AIDS patients who live in the more remote sub-Saharan areas,” said Krista Thompson, vice president and general manager of HIV/AIDS at BD. “Developing the technology to improve the collection and transport of CD4 blood samples and making the new CD4 stabilization tube available in Africa exemplify BD's ongoing commitment to providing the developing world with reliable and affordable monitoring technologies for CD4 testing.”

Health professionals regularly monitor and use CD4 test results to make important treatment decisions in HIV-infected patients, most notably when the disease has progressed to the point where initiation of antiretroviral treatment would be beneficial.

CTLM system shipped to Colombia

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) said that one of its CT Laser Mammography (CTLM) systems has been shipped to Colombia for installation in a private mammography center in Bogota. The center specializes in breast screening as well as diagnostic exams using conventional mammography and ultrasound techniques.

CTLM imaging will be conducted under the direction of Dr. Bernardo Sanchez and his staff. “The system . . . will fit in very well with the modalities and the types of cases that we treat, particularly women with dense breasts and breast implants. We would also like to use CTLM technology to evaluate patients who are undergoing treatment for breast cancer.”

The CTLM system is being installed to generate local physician and patient interest in the new noninvasive laser imaging technology. IDSI has been developing the South American market through a reference system installed in Argentina and through participation in imaging congresses and symposia.

“We are pleased to have placed the first CTLM system in Colombia and expanded our South American position,” said Deborah O'Brien, IDSI senior vice president.

The CTLM system is the first breast imaging system that utilizes state-of-the-art laser technology and patented algorithms to create 3-D images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.