CardioExchange Archive

January 5th, 2015

FDA Approves New Drug-Coated Balloon to Open Blocked Leg Arteries

Larry Husten, PHD

Medtronic said today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication. The new DCB uses the anti-proliferative drug paclitaxel, […]

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May 21st, 2014

Medtronic and Edwards Lifesciences Resolve Patent Disputes

Larry Husten, PHD

After years of protracted and often bitter litigation in the U.S. and abroad, Edwards Lifesciences and Medtronic today announced a broad resolution to all their patent disputes over transcatheter heart valves. Medtronic will pay more than a billion dollars over the course of the agreement, which lasts until April 2022. Edwards will first receive a one-time payment of $750 million, followed […]

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February 13th, 2013

FDA Approves Second-Generation MRI-Friendly Pacemaker System from Medtronic

Larry Husten, PHD

Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next-generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads. Medtronic said that more than 100,000 of its first-generation Revo SureScan devices have […]

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April 10th, 2012

Round Two: Heart Rhythm Editor Rejects St. Jude Request to Retract Riata Paper

Larry Husten, PHD

Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads. On Friday, as electrophysiologist Wes Fisher told CardioExchange, St. Jude issued a press release alleging numerous mistakes and oversights in an article by Robert Hauser published online in Heart Rhythm linking the company’s Riata and […]

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