Medtronic plc announced findings from a new study of the Patient Preferences for the Treatment of Hypertension. The findings will be presented later during the "What's Novel in Interventional Hypertension session" at the 33rd Transcatheter Cardiovascular Therapeutics (TCT 2021) conference, the annual scientific symposium of the Cardiovascular Research Foundation. Medtronic also announced the initiation of the SPYRAL AFFIRM study, evaluating the long-term safety, efficacy, and durability of the Medtronic Symplicity? Renal Denervation System in real-world patients with uncontrolled hypertension and comorbidities such as diabetes, isolated systolic hypertension, and chronic kidney disease. Patient Preference in the Treatment of Hypertension: Interventional Treatments and Standard of Care: For the first time, new data presented at TCT 2021 quantified United States (U.S.) patient preferences for considerations of interventional procedures in the treatment of high blood pressure, including treatment mode, effectiveness and risks. The study found that in exchange for treatment risks, patients on average would require a minimal acceptable benefit of less than 2.5mmHg reduction in office-based systolic blood pressure. Additionally, on average, patients indicated a tolerance of at least 20% risk of adverse events (such as a vascular injury or drug side effects) in exchange for being able to lower their office-based systolic blood pressure. These findings suggest that despite the risks of an intervention, patients may accept lower blood pressure reductions than those observed in published literature of Medtronic Symplicity Spyral Renal Denervation procedure1,2. Additionally, patients may be willing to tolerate risks higher than those observed in peer-reviewed published studies3 of Symplicity Spyral. The study also concluded that blood pressure reduction was the most important driver of patient preference over all other attributes like medication burden and treatment (including interventional treatment-related) risks. When applying this model to a patient population who is interested in an interventional procedure without medication, up to 76.5% of patients would be willing to consider an interventional approach such as RDN if they achieve a 10mmHg reduction in office-based systolic blood pressure. Including the maximum acceptable risk of 20%: 76.5% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 10 mmHg; 24.3% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 5 mmHg; 6.9% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 2.5 mmHg, the minimal acceptable benefit. The study, which was designed based on the FDA Guidance for Patient Preference Information, surveyed 400 individuals in the U.S. who have high blood pressure (physician confirmed systolic office-based blood pressure greater than 140 mmHg), who were on up to three anti-hypertensive medications and were not previously involved in a SPYRAL HTN study. The study uses a statistical method called a discrete choice experiment, often used to compare individuals' preferences among two or more alternatives. SPYRAL AFFIRM Study Launch: Separately, Medtronic announced that the first patient was enrolled at Piedmont Heart Institute in Atlanta, Ga. for the SPYRAL AFFIRM clinical study. Using a performance goal, this clinical study will enroll 1,000 real-world patients with uncontrolled hypertension and associated comorbidities, such as isolated systolic hypertension, diabetes, and chronic kidney disease. SPYRAL AFFIRM will follow these patients for three years. This investigational device exemption trial was approved by the U.S. Food and Drug Administration (FDA) in June 2021 and will be conducted at 100 sites globally. The SPYRAL AFFIRM clinical study is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for RDN. Along with the real-world data from the Global Symplicity Registry,4 when combined with commercial experience, there have been more than 20,000 procedures performed with Medtronic RDN technology. The clinical program is backed by the most rigorous and extensive patient experience studied in the presence and absence of medication and in patients with high baseline cardiovascular risk.