A pair of analyses released during the the European Society of Cardiology Congress in Amsterdam this week showed positive results for the hypertension treatment system.
In 1-year data from the SYMPLICITY registry major complications or serious adverse events associated with denervation were very rare among the more than 1,150 patient enrolled, Medtronic announced. At 6 months only 1 patient needed a procedural dissection and only 1 patient required a re-intervention, representing a 0.09% adverse event rate for each, the Minneapolis-based firm noted.
Symplicity, which delivers radio frequency energy to the renal artery, significantly reduced blood pressure and kept it lower compared to baseline at all time-points up to 12 months when blood pressure was measured both in-office and on-the-go, Medtronic said.
Separate 3-year results from Medtronic’s Symplicity HTN-1 trial, which were accepted for publication in the journal The Lancet, showed that hypertension patients experienced "significant and sustained" decreases in blood pressure following treatment. About half of the patients enrolled achieved goals below 140 mm HG, despite having previously suffered very high blood pressure that was uncontrolled by multiple drugs.
Medtronic’s renal denervation system has had European CE Mark since 2008 and is used in more than 80 countries, but is available for investigational use only in the U.S. The medical device giant earlier this year completed enrollment in its U.S. Symplicity HTN-3 trial with 530 patients.
"It is encouraging that preliminary data with this sizable patient cohort in a real-world setting continue to demonstrate a strong safety profile and significant clinical efficacy for renal denervation with the Symplicity system, similar to what we’ve been seeing in the randomized, controlled clinical trial, Symplicity HTN-2," Global SYMPLICITY Registry co-chair Dr. Michael Bohm said in prepared remarks on behalf of the company.
SYMPLICITY is a global, multi-center, prospective, observational registry to collect long-term procedural and safety cardiovascular data from patients in whom the renal denervation device has been used, including hypertension, stroke, myocardial infarction, heart failure and cardiovascular death, Medtronic explained. The registry also will gather data for diabetes mellitus type 2 and chronic kidney disease.
The registry, the largest and first of its kind in the world, will enroll more than 5,000 patients in a minimum of 200 centers with planned follow-up to 5 years, according to the company.
Of the SYMPLICITY patients treated to date, 66% fall within ESC consensus paper recommendations for catheter-based renal denervation, which call for patients to have a significantly high blood pressure and have taken at least 3 classes of blood-pressure-lowering medications, including diuretic, prior to renal denervation treatment, Medtronic noted.
"We are pleased that enrollment and analysis of the registry continues to meet our goal of establishing procedural safety and efficacy of the Symplicity system, which we expect will ultimately help reduce the risk of cardiovascular events associated with treatment-resistant hypertension such as stroke and ischemic heart disease," Dr. Bohm said.
Ultimately, Medtronic will evaluate the Symplicity renal denervation system in more than 8,000 patients worldwide. In addition to the SYMPLICITY registry, more than 1,200 patients are participating in randomized clinical trials in the U.S., Australia, Europe, and Japan, Medtronic noted.