The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market.
Medtronic beat second-quarter profit and revenue estimates and raised its annual earnings forecast on Tuesday, banking on strong sales in its surgical and diabetes units, sending shares of the company up about 2% in premarket trading. Medical device makers are seeing higher demand for their products due to a steady recovery in surgical procedures that were deferred during the pandemic, especially by older adults, as well as easing staff shortages at hospitals. Medtronic, which makes pacemakers, catheters and tools used in heart and gastrointestinal surgeries, joins Abbott Laboratories and Boston Scientific, which have also benefited from soaring demand for non-urgent surgeries.
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Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
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