Tri-anim changes surgical division name

Tri-anim (Sylmar, California), a provider of specialty sales and distribution solutions for healthcare, said that their surgical division will now be known as Tri-anim surgical solutions.

In December 2004, Tri-anim added a surgical division as a new platform to its distribution organization expanding the scope of its portfolio of specialty healthcare products with a focus on specialty medical devices for use in the operating room. Currently this division alone has over 30 surgical sales representatives and plans to expand in 2008.

Medtronic gets warning letter for Satellite

Medtronic (Minneapolis) was warned by the FDA that a manual for the company’s Satellite spinal device encouraged its use in unapproved ways.

The device is intended to be fused with a bone graft to stabilize and hold together parts of the vertebrae while they heal, the FDA said in a warning letter posted Tuesday on the agency’s website. Medtronic’s surgical technique manual described a nonfusion procedure without implantation of a bone graft, according to the letter, dated Oct. 1.

The instructions represent “major changes or modifications to the cleared intended uses for this device that could significantly affect its safety or effectiveness,” the FDA said. The company has 15 days to explain why the deviations occurred and how the manuals will be recalled.

“We’re looking into our process and trying to figure out how the manual was changed and why it was changed from the one FDA-approved,” said Bert Kelly, a spokesman for Medtronic. He said that it was “a marketing issue” and that no risks to patient safety have been identified.

The Satellite was approved earlier this year and has been used in fewer than 1,000 of the 400,000 spinal fusions performed each year in the U.S., Kelly said.

Coherent gets NASDAQ letter

Coherent (Santa Clara, California) said it has received an additional NASDAQ determination letter saying that the company is not currently in compliance with NASDAQ’s listing requirements due to its failure to hold an annual meeting of stockholders during its fiscal year ended Sept. 30.

Coherent makes laser-based solutions to the commercial and scientific research markets.

Telemedicus opens new headquarters

Telemedicus (Houston), opens new headquarters nearer downtown Houston at 1240 Blalock Road, Ste 210 Houston, Texas 77055. The company recently purchased the Telemedicus technology and subsequently announced the corporation’s name and ticker symbol change. emedicus makes life saving mobile medical communications technology using patented software and communications capabilities.