New Products: St. Jude Renal Denervation; Zimmer Shoulder; Respicardia Sleep Apnea Pulse Generator
This article was originally published in The Gray Sheet
Executive Summary
St. Jude’s next-generation EnligHTN renal denervation system earns a CE mark. Respicardia launches First implant pulse generator to treat central sleep apnea. FDA clears Zimmer shoulder system. GeneDX launches BRCA1 and BRCA2 genetic tests not long after Supreme Court overturns Myriad’s monopoly on the tests.
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St. Jude Halts U.S. Renal Denervation Trial, Citing Slow Patient Enrollment
Patient-recruitment challenges have led St. Jude to halt a U.S. clinical trial of its EnligHTN renal denervation system. The company says it is working with FDA to design a new trial.
Medtronic Renal Denervation System Provides Durable Blood Pressure Benefits In Longest Trial To Date
The latest results from Medtronic’s SYMPLICITY HTN-2 trial show that patients treated for severe hypertension with the company’s Symplicity radio frequency renal denervation system showed a sustained reduction in blood pressure. The firm also announced the start of a renal denervation trial in patients with moderate hypertension.
Myriad Wields Proprietary Database To Protect Testing Market
Myriad president Mark Capone made it clear that the company will use its proprietary database of genetic variants on the BRCA1 and BRCA2 genes to try and fend off cheaper competition after the BRACAnalysis test’s method patents are expired, or if they are overturned in court.