Medtronic reinitiates MSAC application for hypertension procedure

MedTech & Diagnostics News: Amidst a growing number of adults grappling with the complexities of high blood pressure, a minimally invasive procedure known as catheter-based renal denervation (RDN) holds the potential for better clinical outcomes for patients with uncontrolled hypertension (HTN).

The proportion of Australian adults with uncontrolled high blood pressure rises significantly with age, from 10% or less among 18 – 34 year-olds (10% for men and 4.9% for women) to a peak of 47% at age 85 and over (51% for men and 48% for women). Alarmingly, over 620,000 patients in the country are estimated to be taking at least three antihypertensive medications, with about 72% of these patients still unable to manage their hypertension optimally.

Enter Medtronic’s Symplicity Spyral Catheter which is currently the only RDN system in use in the Australian market. The minimally invasive procedure involves the use of radiofrequency (RF) energy to achieve targeted denervation of the renal nerves, allowing for a one-time treatment option in addition to existing standard care.

The journey of this medical procedure began back in 2012 when Medtronic Australia initiated the Medical Services Advisory Committee (MSAC) application. Early enthusiasm was fuelled by positive results from trials like SYMPLICITY HTN-1 and SYMPLICITY HTN-2, showcasing significant blood pressure reductions in patients who underwent the RDN procedure.

However, a turning point came when the single-blind, randomised, sham-controlled clinical trial SYMPLICITY HTN-3 failed to confirm the benefits of RDN on blood pressure compared to the sham procedure, leading to a temporary halt in development. But the setback also sparked renewed determination to improve the design of subsequent clinical trials, as researchers identified confounding factors contributing to the earlier trial’s disappointing outcomes.

Fast forward to the present day, and the medical landscape has shifted dramatically. Rigorous randomised sham-controlled trials like SPYRAL HTN OFF-MED and SPYRAL HTN ON-MED, which employed the next-generation Symplicity Spyral radiofrequency RDN system, have provided compelling evidence supporting RDN as an effective treatment for uncontrolled hypertension.

Buoyed by this positive data, Medtronic now aims to reinitiate the MSAC application process for the inclusion of catheter-based RDN on the MBS, signalling a turning point in the fight against uncontrolled hypertension in Australia.

The proposed patient population for this treatment includes patients with uncontrolled elevated systolic blood pressure of 150 mmHg or higher, despite optimised treatment with three or more antihypertensive drugs, or who cannot tolerate such medications. Clinical experts suggest further limiting RDN to those with the greatest clinical need based on one or more of the following cardiovascular risk factors, including higher systolic BP of 180 mmHg, previous myocardial infarction or stroke, type II diabetes, chronic kidney disease, atrial fibrillation, or heart failure.

While Medtronic’s Symplicity Spyral Catheter is at the forefront of this medical revolution, it is important to note that other RDN systems, such as Abbott Medical Australia’s EnligHTN Ablation Catheter, have been exploring similar avenues. Although the EnligHTN clinical trial has been terminated, the ongoing research and development in this field signify the relentless pursuit of innovative solutions to combat uncontrolled hypertension.

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