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Symplicity flex

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The Symplicity Flex is a medical device designed for use in the treatment of hypertension. It is a catheter-based tool that is used to perform renal denervation, a procedure that targets the nerves surrounding the renal arteries to reduce blood pressure. The Symplicity Flex provides a minimally invasive approach to this treatment.

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Symplicity spyral, by Medtronic (2 mentions)

16 protocols using symplicity flex

1

Renal Nerve Ablation for Hypertension

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Example 1

This section describes an example of the outcome of renal neuromodulation on human patients. A total of 45 patients (mean age of 58±9 years) diagnosed with essential hypertension were treated with percutaneous, catheter based renal nerve ablation. Treatment included RF energy delivery to the renal artery using a single-electrode Symplicity Flex™ catheter commercially available from Medtronic, Inc., of 710 Medtronic Parkway, Minneapolis, Minn. 55432-5604. In this human trial, a radiotracer dilution method was used to assess overflow of norepinephrine from the kidneys into circulation before and 15-30 days after the procedure in 10 patients. Bilateral renal-nerve ablation resulted in a marked reduction in mean norepinephrine spillover from both kidneys: 47% (95% confidence interval) one month after treatment.

In a similar human trial where bilateral renal nerve ablation was performed in 70 patients, whole-body norepinephrine levels (i.e., a measure of “total” sympathetic activity), fell by nearly 50% after renal nerve ablation and measurement of muscle sympathetic nerve activity showed a drop of 66% over 6 months, further supporting the conclusion that total sympathetic dive was reduced by the renal denervation procedure in this patient group.

US11350992B2. Neuromodulation and associated systems and methods for the treatment of cancer (2022-06-07). Medtronic Ardian Luxembourg S.a.r.l. [LU]. Inventors: Garrett Pilcher [US], Robert Melder [US].
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2

Renal Neuromodulation for Hypertension

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Example 1

This section describes an example of the outcome of renal neuromodulation on human patients. A total of 45 patients (mean age of 58±9 years) diagnosed with essential hypertension were treated with percutaneous, catheter based renal nerve ablation. Treatment included RF energy delivery to the renal artery using a single-electrode Symplicity Flex™ catheter commercially available from Medtronic, Inc., of 710 Medtronic Parkway, Minneapolis, Minn. 55432-5604. In this human trial, a radiotracer dilution method was used to assess overflow of norepinephrine from the kidneys into circulation before and 15-30 days after the procedure in 10 patients. Bilateral renal-nerve ablation resulted in a marked reduction in mean norepinephrine spillover from both kidneys: 47% (95% confidence interval) one month after treatment.

In a similar human trial where bilateral renal nerve ablation was performed in 70 patients, whole-body norepinephrine levels (i.e., a measure of “total” sympathetic activity), fell by nearly 50% after renal nerve ablation and measurement of muscle sympathetic nerve activity showed a drop of 66% over 6 months, further supporting the conclusion that total sympathetic dive was reduced by the renal denervation procedure in this patient group.

US10945788B2. Methods for treating depression in patients via renal neuromodulation (2021-03-16). Medtronic Ardian Luxembourg S.a.r.l. [LU]. Inventors: Marcia Gallagher [US], Douglas Hettrick [US].
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3

Renal Nerve Ablation for Hypertension

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Example 1

This section describes an example of the outcome of renal neuromodulation on human patients. A total of 45 patients (mean age of 58±9 years) diagnosed with essential hypertension were treated with percutaneous, catheter based renal nerve ablation. Treatment included RF energy delivery to the renal artery using a single-electrode Symplicity Flex™ catheter commercially available from Medtronic, Inc., of 710 Medtronic Parkway, Minneapolis, Minn. 55432-5604. In this human trial, a radiotracer dilution method was used to assess overflow of norepinephrine from the kidneys into circulation before and 15-30 days after the procedure in 10 patients. Bilateral renal-nerve ablation resulted in a marked reduction in mean norepinephrine spillover from both kidneys: 47% (95% confidence interval) one month after treatment.

In a similar human trial where bilateral renal nerve ablation was performed in 70 patients, whole-body norepinephrine levels (i.e., a measure of “total” sympathetic activity), fell by nearly 50% after renal nerve ablation and measurement of muscle sympathetic nerve activity showed a drop of 66% over 6 months, further supporting the conclusion that total sympathetic dive was reduced by the renal denervation procedure in this patient group.

US11284934B2. Methods for treating sleep disorders in patients via renal neuromodulation (2022-03-29). Medtronic Ardian Luxembourg S.a.r.l. [LU]. Inventors: Gabriel Lazarus [US], Douglas Hettrick [US].
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4

Renal Denervation Procedure with Symplicity Catheters

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Renal denervation was performed using Symplicity Flex or Symplicity Spyral (Medtronic) catheter and corresponding radio-frequency generator. Arterial access catheter was inserted after puncturing the common femoral artery using modified Seldinger technique. After the cannulation of the artery, 5000 heparin units were administered to manage anticoagulation. A guiding catheter was then advanced over 0.035-inch wire to cannulate renal artery and an angiography of the renal arteries was performed with manual contrast-media injection. An RDN catheter was then positioned distally in the renal artery. Radiofrequency ablation was initiated if the contact with the arterial wall was proper: a flat impedance curve was displayed on the generator. Then catheter was pulled back proximally towards the aorta and rotated about 90 degrees and radiofrequency ablation was repeated. The number of radiofrequency ablations depended on the vascular anatomy. The complete procedure was then repeated with the other renal artery. If angiography showed accessory renal arteries of >3 mm in diameter, the radiofrequency ablation procedure was repeated in these arteries following the same methodology. After the procedure, all patients received Aspirin or Clopidogrel for at least 1 month.
Berukstis A., Navickas R., Neverauskaite-Piliponiene G., Ryliskyte L., Misiura J., Vajauskas D., Misonis N, & Laucevicius A. (2019). Arterial Destiffening Starts Early after Renal Artery Denervation. International Journal of Hypertension, 2019, 3845690.
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5

Renal Denervation for Resistant Hypertension

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Bilateral renal denervation (RDN) was performed for the patients with resistant hypertension using a radiofrequency ablation catheter (Symplicity Flex ® or Symplicity Spiral ®, Medtronic, Palo Alto, CA, USA) as described previously [51 ]. Briefly, the ablation catheter was placed via a. femoralis communis and positioned in the renal artery using X-ray guidance. After that, the electrode(s) were heated to about 55–65 degrees Celsius, a temperature high enough to induce nerve fiber damage within the artery wall. In the cases where a Symplicity Flex catheter was used, the catheter was withdrawn 5mm after each ablation to ensure circular ablation within the renal artery, as the catheter uses one radiofrequency electrode. The Symplicity Spiral catheter, however, has a helical shape, and the catheter consists of four electrodes enabling ablation at multiple points simultaneously. The procedure was performed in both renal arteries, and 4–6 points were ablated per renal artery.
Kantauskaite M., Vonend O., Yakoub M., Heilmann P., Maifeld A., Minko P., Schimmöller L., Antoch G., Müller D.N., Schmidt C., Duvnjak B., Zierhut U., Potthoff S.A., Rump L.C., Fischer J.C, & Stegbauer J. (2023). The Effect of Renal Denervation on T Cells in Patients with Resistant Hypertension. International Journal of Molecular Sciences, 24(3), 2493.
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6

Renal Denervation Procedure and Outcomes

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Radiofrequency RDN was performed using either the first-generation single-electrode Symplicity Flex or the current-generation 4-electrode Symplicity Spyral catheter (Medtronic plc, Santa Rosa, CA). The procedural technique has been described elsewhere.9 (link),10 (link),18 (link) Patients were followed at 6, 12, 24, and 36 months after the procedure per standard of care. Office and 24-hour ambulatory BP was measured at baseline before the RDN procedure and at each follow-up visit.19 (link) Prescribed antihypertensive medication classes were catalogued although dosages were not reported. Adverse events included myocardial infarction (MI), stroke, hospitalization for heart failure, cardiovascular death, all-cause death, and composite events comprising of all of the above were recorded through 36 months. Adverse events were independently adjudicated by the Clinical Events Committee (Cardiovascular Research Foundation, New York, NY).
Mahfoud F., Mancia G., Schmieder R.E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M, & Böhm M. (2023). Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension (Dallas, Tex. : 1979), 80(8), 1759-1770.
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7

Renal Denervation in Chronic Kidney Disease

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In these sheep, arterial pressure and kidney function were assessed at 6 months of age to establish baseline and these data have been previously reported71 (link). At 10 months of age, animals were randomly assigned to receive either RDN procedure (six, two-minute radiofrequency ablations per artery) or sham-procedure using the Symplicity Flex catheter (Symplicity, Medtronic Ardian Inc, CA) as previously described29 (link). This resulted in four groups; control-RDN; N = 7, CKD-RDN; N = 7, control-intact; N = 6 and CKD-intact; N = 7.
Singh R.R., McArdle Z., Singh H., Booth L.C., May C.N., Head G.A., Moritz K.M., Schlaich M.P, & Denton K.M. (2021). Blunted natriuretic response to saline loading in sheep with hypertensive kidney disease following radiofrequency catheter-based renal denervation. Scientific Reports, 11, 14795.
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8

Global SYMPLICITY Registry: Renal Denervation Outcomes

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Details of the design of the international, prospective, single-arm Global SYMPLICITY Registry (NCT01534299) have previously been published.20 (link) Patients with uncontrolled hypertension or conditions associated with sympathetic nervous system activation were enrolled according to local guidelines. The institutional review board or ethics committee at each enrolling site approved the registry, the study design adhered to the Declaration of Helsinki and all patients provided written informed consent. All patients were treated with the Symplicity renal denervation system (Medtronic, Santa Rosa, CA, USA) using either the single electrode Symplicity Flex™ or the multi-electrode Symplicity Spyral™ catheter to accomplish radiofrequency ablation of the renal nerves. Patients were followed at 3-, 6-, 12-, 24- and 36-months post-procedure. Adverse event occurrence, including death, stroke, myocardial infarction, were recorded at each follow-up and were independently adjudicated by the Clinical Events Committee (Cardiovascular Research Foundation, New York, NY, USA).
Schmieder R.E., Mahfoud F., Mancia G., Narkiewicz K., Ruilope L., Hutton D.W., Cao K.N., Hettrick D.A., Fahy M., Schlaich M.P., Böhm M, & Pietzsch J.B. (2022). Clinical event reductions in high-risk patients after renal denervation projected from the global SYMPLICITY registry. European Heart Journal. Quality of Care & Clinical Outcomes, 9(6), 575-582.
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9

Renal Neuromodulation and Hypertension

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Example 1

This section describes an example of the outcome of renal neuromodulation on human patients. A total of 45 patients (mean age of 58±9 years) diagnosed with essential hypertension were treated with percutaneous, catheter based renal nerve ablation. Treatment included RF energy delivery to the renal artery using a single-electrode Symplicity Flex™ catheter commercially available from Medtronic, Inc., of 710 Medtronic Parkway, Minneapolis, Minn. 55432-5604. In this human trial, a radiotracer dilution method was used to assess overflow of norepinephrine from the kidneys into circulation before and 15-30 days after the procedure in 10 patients. Bilateral renal-nerve ablation resulted in a marked reduction in mean norepinephrine spillover from both kidneys: 47% (95% confidence interval) one month after treatment.

In a similar human trial where bilateral renal nerve ablation was performed in 70 patients, whole-body norepinephrine levels (i.e., a measure of “total” sympathetic activity), fell by nearly 50% after renal nerve ablation and measurement of muscle sympathetic nerve activity showed a drop of 66% over 6 months, further supporting the conclusion that total sympathetic dive was reduced by the renal denervation procedure in this patient group.

US10646713B2. Systems, devices, and associated methods for treating patients via renal neuromodulation to reduce a risk of developing cognitive impairment (2020-05-12). Medtronic Ardian Luxembourg S.a.r.l. [LU]. Inventors: Douglas Hettrick [US], Gabriel Lazarus [US].
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10

Renal Neuromodulation: Reducing Hypertension

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Example 1

This section describes an example of the outcome of renal neuromodulation on human patients. A total of 45 patients (mean age of 58±9 years) diagnosed with essential hypertension were treated with percutaneous, catheter based renal nerve ablation. Treatment included RF energy delivery to the renal artery using a single-electrode Symplicity Flex™ catheter commercially available from Medtronic, Inc., of 710 Medtronic Parkway, Minneapolis, Minn. 55432-5604. In this human trial, a radiotracer dilution method was used to assess overflow of norepinephrine from the kidneys into circulation before and 15-30 days after the procedure in 10 patients. Bilateral renal-nerve ablation resulted in a marked reduction in mean norepinephrine spillover from both kidneys: 47% (95% confidence interval) one month after treatment.

In a similar human trial where bilateral renal nerve ablation was performed in 70 patients, whole-body norepinephrine levels (i.e., a measure of “total” sympathetic activity), fell by nearly 50% after renal nerve ablation and measurement of muscle sympathetic nerve activity showed a drop of 66% over 6 months, further supporting the conclusion that total sympathetic dive was reduced by the renal denervation procedure in this patient group.

US10736692B2. Neuromodulation and associated systems and methods for the treatment of cancer (2020-08-11). Medtronic Ardian Luxembourg S.a.r.l. [LU]. Inventors: Garrett Pilcher [US], Robert Melder [US].
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