Devices for HFrEF, hypertension to be discussed over 2 days
WASHINGTON -- Cardiac contractility modulation (CCM) therapy and renal denervation will get an airing before a FDA advisory committee panel over 2 days starting Tuesday.
On Dec. 4, the committee will discuss and vote on approval for the premarket application of Impulse Dynamics' Optimizer Smart Implantable Pulse Generator to provide CCM therapy for class III heart failure patients who are not responding to optimal medical therapy.
Optimizer Smart Implantable Pulse Generator
FDA panelists will weigh the benefits and risks of the pulse generator based mainly on the results from the FIX-HF-5C trial, which has shown less decline in mean peak oxygen consumption with the device at 24 weeks compared to controls. The 90.5% complication-free rate will also be up for discussion on safety.
CCM therapy is the delivery of non-excitatory electrical signals to the myocardium of the heart to increase ventricular contractile strength, a way of improving systolic function without increasing myocardial oxygen consumption.
Of note, the trial had its sample size reduced from 230 to 160 subjects as a result of the device getting "breakthrough" designation. Also, 30% of participants were borrowed from the prior FIX-HF-5 study.
The subcutaneous implant is being looked at as an option for patients with QRS <120 mson ECG, a group not indicated for cardiac resynchronization therapy. The proposed indication for use is in heart failure patients with left ventricular ejection fraction in the 25% to 45% range.
"More data and more impact are likely necessary before general cardiology embraces yet another heart failure device," commented Clyde Yancy, MD, MSc, of Northwestern Memorial Hospital in Chicago.
"As it currently is evolving, the [CCM therapy] market will be a niche market with modest benefits. But, the advantage is the awareness of a novel approach to modulate ventricular function that through additional research may provide greater benefits to more patients," he told MedPage Today.
Device-based hypertension treatment gets its turn before an FDA advisory committee panel on Dec. 5 as members re-convene to make recommendations for potential indications, trial design, and post-approval study design.
Renal denervation, as the technique with the most evidence backing its reduction in blood pressure, will take up the bulk of the meeting. Other hypertension therapies up for discussion include carotid body ablation, carotid baroreceptor stimulation, and hemodynamic modulation.
Panelists will discuss recent "off medication" renal denervation trials -- SPYRAL HTN-OFF MED for Medtronic's Symplicity Spyral device and RADIANCE-HTN SOLO for ReCor Medical's Paradise device -- and the "on medication" counterparts, SPYRAL HTN-ON MED and RADIANCE HTN-TRIO.
Who the right patients are for this therapy will be up for debate, because the trials included different patient demographics. Panelists will also make recommendations on whether a sham group is still needed in future studies, and whether both "on" and "off" medication study designs are still needed.
Importantly, deliberations will also touch on the acceptability of ambulatory blood pressure as a surrogate endpoint when evaluating long-term cardiovascular risk.
Finally, the FDA will ask the panel to weigh how patient preference, drug adherence, and other considerations might affect the benefit-risk profile of these devices.
Watch for MedPage Today's on-site coverage of these deliberations.
Read the original article on Medpage Today: FDA Panel to Review Heart Contractility Booster, Renal Denervation