Medtronic Launches Global EMBRACE Trial: A New Hope for Patients with Resistant Hypertension and Multivessel Coronary Artery Disease

Apr 06, 2026 08:00 CST Updated 08:00

Medtronic

Medical Device Manufacturer

On April 2, 2026, medical giant Medtronic officially announced the launch of a global multicenter randomized trial named EMBRACE! This trial targets a clinical challenge—patients suffering from both refractory hypertension and multivessel coronary artery disease—to explore the effects of combined "renal denervation + staged PCI" treatment compared to staged PCI alone, offering new therapeutic possibilities for these high-risk patients.

Medtronic | Medtech Big 100 largest medical device companies

First, let me give you a通俗explanation of two key treatment methods to avoid confusion with technical jargon:

Staged PCI: Percutaneous Coronary Intervention in full, simply put, it is a minimally invasive method to clear narrowed or blocked coronary arteries and "unleash" the heart's "blood supply pathway." It is an important minimally invasive treatment for coronary heart disease, akin to performing "road maintenance" on clogged blood vessels without the need for surgery, minimal trauma, and quick recovery.

Renal Denervation (RDN): This trial utilized Medtronic's Symplicity Spyral Renal Denervation System, which precisely "calms" overactive sympathetic nerves around the renal arteries using radiofrequency energy—these nerves act like "telephone lines" constantly sending "raise blood pressure" signals to the brain, and their overactivity can lead to persistently high blood pressure. The procedure is also minimally invasive, performed via a puncture in the wrist or groin, with the catheter delivering mild radiofrequency energy that does not damage blood vessels but blocks incorrect signals, helping to lower blood pressure and reduce the burden of taking antihypertensive medications.

This EMBRACE trial aims to determine whether combining these two minimally invasive approaches provides better protection for the heart health of patients with both conditions compared to staged PCI alone.

01.Core Details of the Trial, All in One Article

This trial is jointly led by two authoritative experts: Professor Roxana Mehran from the Icahn School of Medicine at Mount Sinai, New York, USA, and Professor Felix Mahfoud from University Hospital Basel, Switzerland, representing a top-tier professional lineup.

Trial Scope: Covering 20 countries worldwide, 55 research centers, including the United States, Europe, and Asia, with a plan to recruit 1,000 patients—all of whom suffer from multi-vessel coronary artery disease and concurrent refractory hypertension, and are undergoing staged PCI treatment.

Observation Period: The primary endpoint will be assessed at 2 years post-operation, while the total follow-up period will be extended to 3 years to ensure long-term observation of treatment effects and avoid limitations of short-term data.

Evaluation Criteria: The focus is on the "composite endpoint," which simply means assessing the probability of serious adverse events such as cardiovascular death, stroke, myocardial infarction, hospitalization for heart failure, or hypertensive crisis occurring in patients post-surgery to determine the clinical effectiveness of combination therapy.

02.Why Conduct This Test? There's a Deep Meaning Behind It

Refractory hypertension is a major driver of coronary heart disease progression and recurrent ischemic events.

——Jason Weidman, Senior Vice President of Medtronic's Coronary and Renal Denervation Business

This statement hits the clinical pain point—many coronary heart disease patients undergo PCI, their blood vessels are cleared, but their blood pressure remains uncontrollable, still facing a high risk of recurrence.

Hypertension and coronary heart disease are "partners in crime": Long-term hypertension can damage the vascular endothelium, accelerate atherosclerosis, and worsen coronary artery stenosis, while coronary heart disease can affect cardiac function, further leading to unstable blood pressure. Global guidelines clearly state that patients with these dual diseases require more aggressive hypertension management, and the EMBRACE trial is precisely aimed at filling this treatment gap.

PCI is no longer the endpoint of treatment but the starting point for addressing residual cardiovascular risk.

——Lead Expert Professor Roxana Mehran

She believes that refractory hypertension is the key to the recurrence of the patient's condition, and what this trial explores is precisely the combination of "revascularization (PCI) + renal denervation," hoping to shift from "passive intervention" to "active prevention" and truly reduce the long-term risks for patients.

It is worth mentioning that this trial was investigator-initiated and funded by Medtronic, aligning with clinical needs while ensuring the professionalism and rigor of the study. Jason Fontana, Vice President of Medtronic's Renal Denervation business, stated that he hopes this trial will further enhance the clinical evidence for the Symplicity system, helping high-risk patients better manage cardiovascular risks.

03.Additional Surprise! Symplicity System Gains New Evidence

Symplicity Spyral™ Multi Electrode Renal Denervation System is the ...

Just before the launch of the EMBRACE trial, on March 28-30 at the American College of Cardiology’s Annual Scientific Session (ACC.26), Professor Michael Böhm from Saarland University in Germany presented another significant study result of the Symplicity Spyral Renal Denervation System — a pooled analysis of the SPYRAL HTN ON and OFF MED trials.

This analysis, covering 703 patients (388 receiving renal denervation and 315 in the sham control group), showed that during the three-year follow-up period, the incidence of hypertensive emergencies was significantly reduced by 40% in the renal denervation group compared to the control group!

More specific data shows:

Cumulative incidence of hypertensive emergencies over three years: 0.21 episodes per patient in the renal denervation group versus 0.39 episodes in the control group (HR 0.60, 95% confidence interval 0.40-0.90, p=0.014), with a statistically significant difference;
Medication Burden: Three years later, the medication intake of patients in the renal denervation group was significantly lower than that of the control group (3.7±4.3 vs. 6.0±11.2, p=0.003), meaning patients could reduce their antihypertensive drug consumption, alleviating both economic burden and potential side effects from long-term medication use.

要知道，Symplicity Spyral系统早已不是“新手”——它自2013年获得欧洲CE认证后，已在70个国家投入使用，2023年还获得了美国FDA批准，此次新数据，进一步印证了它在降压和减少不良事件方面的优势。

04.Summary: A New Dawn for Patients with Dual Diseases

For patients suffering from both refractory hypertension and multi-vessel coronary artery disease, the launch of the EMBRACE trial is undoubtedly a significant beacon of hope. It breaks the traditional model of "PCI only unblocks blood vessels, and blood pressure reduction relies on medication," exploring a new path of "minimally invasive combination therapy" that could potentially reduce the risk of cardiovascular event recurrence at its root.

New research data on the Symplicity Spyral system also reveals the potential of renal denervation — not only can it effectively lower blood pressure, but it can also reduce hypertensive crises and the burden of medication, making it especially suitable for patients who do not respond well to drugs or cannot tolerate the side effects of medications.

We will continue to follow the progress of the EMBRACE trial and share the 2-year and 3-year follow-up results as soon as possible. Let us look forward to this global trial bringing new breakthroughs in cardiovascular treatment, allowing more patients with dual conditions to overcome their challenges and enjoy a more reassuring life ❤️

Tip: This article is for scientific popularization only and does not constitute medical advice. If you have concerns related to hypertension or coronary heart disease, please consult a professional cardiologist promptly and follow medical instructions for treatment.