St. Jude Medical Inc. has received FDA approval for software and firmware updates to its Internet-based data management system for implantable cardiac devices. The Merlin.net PCN (Patient Care Network) will now enable doctors to remotely monitor patients nationwide, who send data via phone lines. The updated version also allows patients with these implantable cardiac devices to transmit data from outside the U.S.

Johnson & Johnson has received FDA approval for its anti-HIV drug Intelence for treating patients resistant to other HIV therapies. The FDA had granted the drug, which is also known as etravirine or TMC125, a priority review status. The company expects to make the drug available in the U.S. wholesale market within a week. The drug is still awaiting approval in Canada, Europe, Australia, Switzerland and Russia.

The U.S. Food and Drug Administration (FDA) has expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.

The sealant, called Evicel, which is manufactured by OMRIX Biopharmaceuticals, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.

A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.

FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.

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Varian Medical Systems has received an FDA 510(k) approval for its RapidArc radiotherapy technology, which makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than is possible with conventional IMRT or helical tomotherapy.

RapidArc delivers a complete IMRT treatment in a single rotation of the treatment machine around the patient. The two FDA clearances for RapidArc cover the treatment hardware and the RapidArc treatment planning software module in Varian’s Eclipse treatment planning system. Varian will begin taking orders for RapidArc immediately, and will begin delivering it to customers in the spring of 2008.

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Voluven, an intravenous synthetic starch solution, has received FDA approval for use in surgery as a blood volume expander. Blood volume expanders are used to quickly restore some of the blood volume lost during surgery so that remaining red blood cells can continue to deliver oxygen to the body’s tissues. Voluven is manufactured by Fresenius Kabi, a German company.

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Merit Medical Systems, Inc. has received FDA approval for its new Sea Dragon torque device. The device is used specifically with hydrophilic guide wires. It was recently released in Europe. The company plans to release the Sea Dragon product in the U.S. in January 2008.

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