St. Jude gets FDA regulatory, market approval for world's thinnest ICD lead

By Elaine Rigoli

Tampa, Fla., April 10 - St. Jude Medical, Inc. announced Food and Drug Administration regulatory approval and market launch of the Riata ST lead, what the company says is the world's thinnest implantable cardioverter defibrillator lead.

The thin size is designed to make navigation easier through difficult anatomy in cardiac patients, enabling physicians to place leads more precisely, which is critical for successful therapy, according to a news release.

The thin diameter of the Riata ST lead preserves venous space, an important consideration when treating patients with implantable devices, especially those with pre-existing or multiple lead systems, because it minimizes restriction to blood flow, officials said.

"The Riata ST lead has design enhancements such as silicone back-filled coils and a low profile wire to create a smaller lead that is more isodiametric, engineered to give physicians both ease of implant and the potential for reduced tissue in-growth," said Michael J. Coyle, president of St. Jude's cardiac rhythm management division, in a statement.

The reduction in diameter for the Riata ST lead relative to previous versions of the family was achieved primarily through a flatware component technology that allows for reduction in the diameter of the lead's conductor coil.

This change, along with other improvements made to the Riata lead design, enable improved lead handling characteristics without compromising the long-term performance of the lead, the release said.

The new lead, to be launched in the United States on April 17, provides steroid-elution, a time-released delivery of a steroid near the pacing electrode, which is intended to improve the long-term pacing threshold.

Headquartered in St. Paul, Minn., St. Jude makes products for cardiac, neurological and chronic pain patients.

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