Results from the 2,600-patient trial, which has 2,300 patients past the three-year mark, showed that ablation of nerves lining the renal arteries lowered in-office blood pressure measurements by 16.5mm Hg and cut ambulatory blood pressure measurements by 8.9mm Hg, the Fridley, Minn.-based company said at the annual EuroPCR meeting in Paris.
The reductions were consistent and sustained across high-risk sub-groups including patients with diabetes, isolated systolic hypertension, chronic kidney disease, resistant hypertension and those aged 65 years and up, Medtronic said.
Another, physician-sponsored trial showed that renal denervation lowered the occurrence of subclinical atrial fibrillation in high-risk patients with hypertensive heart disease at a median follow-up of two years, the company said at the conference. The 80-patient study randomized subjects to either RDN treatment with Symplicity or a sham procedure and then tracked them for AF episodes using an implantable Medtronic monitor. The Symplicity-treated cohort developed subclinical AF at a 19% rate, compared with 47% for the sham arm.
“In this high-risk cohort of patients with hypertensive heart disease, who are at risk for atrial fibrillation and cardiovascular death, this study suggests there may be an important benefit provided by renal denervation,” principal investigator Dr. Marshall Heradien, of Cape Town’s Stellenbosch University, said in prepared remarks. “Consistent with previous studies, these data show that the RDN procedure offers a lasting, positive effect that may translate into improved clinical outcomes.”
“As demonstrated by these studies presented at EuroPCR, new data continue to demonstrate that renal denervation is a safe and useful complement to manage uncontrolled hypertension, with patients experiencing meaningful blood pressure reductions out to several years and in the setting of daily clinical practice,” added coronary & renal denervation GM Dave Moeller. “Results from these studies will add to the robust growing body of evidence supporting renal denervation and may be important for consideration with patients suffering from uncontrolled hypertension.”
Edwards Lifesciences touts 6-month Pascal mitral data, FDA approval for U.S. trial
The Pascal transcatheter mitral valve repair device made by Edwards Lifesciences (NYSE:EW) presented six-month data from the Clasp trial of its Pascal mitral valve repair device and said the FDA approved a U.S. pivotal study of the device.
The six-month Clasp results, presented by Dr. Konstantinos Spargias of Athens’ Hygeia Hospital, showed “clinically and statistically significant improvements in functional status, exercise capability and quality of life,” Irvine, Calif.-based Edwards said.
The company also said that the FDA approved its Clasp IIF pivotal study, which is designed to compare Pascal with Abbott’s Mitraclip device in moderate-to-severe or severe mitral regurgitation. Enrollment is slated to begin in “the next few months,” Edwards said. The company is already running Clasp IID pivotal trial in patients with symptomatic primary mitral regurgitation.
“Each of these milestones, including the positive Clasp study results, the approval of the pivotal Clasp IIF trial and the pivotal Clasp IID trial already enrolling, support our strategy to lead and transform the treatment of patients with mitral valve disease,” transcatheter mitral & tricuspid vice president Bernard Zovighian said in prepared remarks. “We look forward to the ongoing follow-up on these clinical and regulatory milestones to further validate these early results.”
Abbott touts Triluminate TTVR study
Abbott (NYSE:ABT) presented results for its transcatheter tricuspid valve repair device at the conference showing a reduction in tricuspid regurgitation symptoms at 30 days.
The 85-patient study is a prospective, single-arm trial designed to evaluate the safety and performance of the tricuspid valve repair system, which is based on Abbott’s Mitraclip mitral valve repair device. Some 86.6% of patients in the trial showed at least a one-grade reduction in tricuspid regurgitation severity and an increase in the number of patients with lowered NYHA classification, with 80.5% categorized NYHA Class I or Class II at 30 days, compared with 25.6% at baseline. Self-assessed social ability, symptom, and quality-of-life scores also improved, from 53.1 at baseline to 67.3 at the 30-day mark (a five-point increase is considered clinically significant, Abbott said). Triluminate is slated to continue following patients at the six-month, one-, two- and three-year marks.
“Treating a leaky tricuspid heart valve has long presented a significant challenge for cardiologists because it is an extremely complex and difficult heart valve to treat,” lead investigator Dr. Georg Nickenig, of Bonn’s University Hospital, said in prepared remarks. “These data are extremely encouraging and I am excited about the potential of transcatheter tricuspid valve repair as a minimally invasive treatment option for these very ill patients who have no other options.”
“Abbott’s experience in developing minimally invasive technologies to help people with heart valve diseases avoid surgery is unparalleled,” added structural heart VP Michael Dale. “These data show that our clip-based approach – for the first time ever – may offer a proven treatment for an extremely difficult-to-treat disease that is associated with high mortality.”