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New Treatment From Shockwave Medical For Clogged Arteries Gets CMS Pass-Through Payment

 
• By Brian Bossetta

Starting 1 July, Medicare beneficiaries with a certain type of cardiovascular disease will be able to receive an innovative treatment covered under their government plans.

Physicians monitoring stent procedure.
PHYSICIANS MONITOR A STENT PROCEDURE. • Source: Alamy

The Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through (TPT) payment for a novel therapy from Shockwave Medical, Inc. designed to clear hardened arterial plaque prior to stent implantation in hospital outpatient settings.

Approved by the US Food and Drug Administration in February 2021,the Shockwave IVL (intravascular lithotripsy) System along with the Shockwave C2 Coronary IVL Catheter applies a technology used for decades to treat kidney stones – lithotripsy – to open blockages in arteries that have become too hard for traditional angioplasties to work effectively

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• By Amanda Maxwell

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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

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FDA Announces Classifications On 9 Device Types

 
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Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

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