Medtronic Harmony

2022: Recall of defective cardiac valve prosthetics catheters

On April 26, 2022, the U.S. Food and Drug Administration (FDA) reported that Medtronic is recalling cardiac valve prosthetics catheters used with Harmony's transcatheter pulmonary valve (TLC) system due to the risk of capsule failure during use. The agency defined this as a recall of class I, which has the highest priority.

The Harmony TPV system was approved in 2021 as the first non-surgical heart valve for the treatment of severe pulmonary regurgitation in children and adults with native or surgically restored right ventricular outflow (RVOT). The official recall concerns only the catheter that is used to implant the Harmony valve.

April 26, 2022 US Food and Drug Administration (FDA) reported that Medtronic is recalling cardiac valve prosthetics catheters used with Harmony's transcatheter pulmonary valve (TLC) system due to the risk of capsule failure during use. The Office defined this as a Class I recall with the highest priority.

In total, the recall, begun on March 2, 2022, affected 665 devices distributed between April 7, 2021 and January 26, 2022. There have been six complaints from clinical cases, one injury and zero device-related deaths all the time, the FDA said in a release.

Medtronic withdrew the catheter for the Harmony heart valve prosthetics due to the relatively high possibility that the connection holding the capsule at the end of the catheter may break during the TPV installation procedure. Rupture of the capsule compound during surgery can cause serious harm to the patient, including the risk of preventing blood flow and/or complete blocking (embolization or occlusion), rupture and/or separation (perforation or dissection) and other types of damage to the patient's blood vessels.

The company's customers were ordered to remove all unused products from use and return them to Medtronic, as well as suspend new cases of using Harmony TPV systems.^[1]

2021: Pulmonary Valve Launch

In mid-April 2021, Medtronic announced the launch of sales of Harmony's unique pulmonary valve for children and adult patients with severe pulmonary artery valve regurgitation, which is usually a consequence of congenital heart disease and requires serious surgery. Harmony's transcatheter system offers a less invasive alternative to open heart surgery and will be the first nonsurgical valve approved to treat these patients.

Harmony is a self-expanding transcatheter valve. The device is implanted through a catheter carried into the vein on the groin or neck. The compressed valve is released into the outlet tract of the right ventricle, where it independently expands, providing normal blood flow from the heart to the lungs.

Medtronic Begins Delivery to Medtronic Harmony Pulmonary Valve Market

The Harmony valve was originally designated a revolutionary device, which significantly accelerated its development. A clinical trial involving 70 patients brought excellent news: all patients reached the main safety endpoint - no death within 30 days of implantation, and 89.2% of patients with echocardiography data reached the main efficacy endpoint - acceptable blood flow within 6 months in the absence of additional device-related procedures. After regulatory approval, the follow-up period for these patients was increased from 5 years to 10 years.

Using the Medtronic Harmony valve can help patients not only delay necessary surgeries, but also reduce the number of open-heart repeat surgeries needed throughout life to treat the condition, the developers said. Thus, the use of a new transcatheter system will significantly improve the quality of life of patients and allow a faster return to normal activities after surgery.^[2]

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