Interventional Cardiology: IVL's new reimbursement rate | FDA approves 2 RDN systems | Catheter kits recalled

Intravascular lithotripsy therapy to break up calcified coronary lesions will now be reimbursed at a higher rate under new in-hospital codes the went into effect Oct. 1.

The system, designed for patients with uncontrolled hypertension who are unresponsive to medication, uses ultrasound ablation to target nerves in the renal arteries, increasing blood flow. This approval comes just months after an FDA advisory panel voted in favor of the system. 

A cardiologist-led think tank tracked data from more than 1 million procedures, exploring the clinical and economic impacts of implanting low-value coronary stents. 

This is the second time in a matter of weeks the FDA has approved an RDN system for uncontrolled hypertension. The SCAI issued a statement about this trend, calling it a “game-changer for both interventional cardiology and the treatment of hypertension."

Medical facilities and distributors have been advised to immediately discontinue the use of these devices due to a significant labeling issue. 

Robert Yeh, MD, detailed the importance of the pivotal AGENT IDE trial, which focused on the use of a paclitaxel-coated balloon to treat in-stent restenosis. 

There were some concerns among researchers after one study suggested iFR may increase the risk of mortality. New data presented at TCT 2023, however, showed that the two technologies are linked to similar outcomes. 

“Going forward, patients and medical teams have a choice of two pathways for chest pain relief: chest pain medication or PCI," one cardiologist said. 

IVUS was especially effective when treating patients with a complex coronary anatomy, researchers found.