Abbott Provides Updates on PFA Study Milestones, Cardiac Mapping Clearance
The company said the trials represent significant advances for the future of two Abbott PFA catheters.
Announcing major milestones for the company’s suite of pulse field ablation (PFA) devices in electrophysiology, Abbott Laboratories said it is advancing treatment for patients with abnormal heart rhythms like atrial fibrillation (AFib).
The company reported that it has completed enrollment early for its Volt-AF IDE (investigational Device Exemption) study of the Volt PFA system, has launched its FocalFlex trial to assess the TactiFlex Duo Ablation Catheter, Sensor Enabled (SE) for use in the treatment of patients with paroxysmal AFib, and received FDA clearance for the Advisor HD Grid X Mapping Catheter.
Historically, patients requiring a cardiac ablation procedure to treat conditions like AFib received FR ablation, which uses heat to destroy tissue responsible for erratic heart signals, or cryogenic ablation, which freezes tissue. However, these procedures have increased risk of damaging adjacent tissue when a patient has complex disease or anatomy.
Abbott’s PFA systems have evolved to reduce known risks of traditional ablation therapies, as well as issues with early generations of PFA itself. PFA uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, reducing potential adjacent tissue damage. Early- generation PFA system limitations include a lack of three-dimensional visualization, coupling with a 3D mapping system, no indication of catheter-tissue contact, and repeat ablations to ensure favorable patient outcomes. Abbotts’ studies, like the Volt-AF IDE study and FocalFlex trial, aim to overcome prior limitations in PFA systems.
"There's immense value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique," said professor Prash Sanders, MBBS, PhD, director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with the TactiFlex Duo Ablation Catheter, SE for the FocalFlex trial, in the release. "Abbott improved upon limitations of first-generation systems and has successfully advanced its approach to PFA beyond those initial systems that have come to market."
Due to increased interested in the technology, the company saw the Volt-AF IDE study complete enrollment four months ahead of the anticipated timeline, enrolling almost 400 patients in three months. The investigational system was designed to step the needle forward for PFA system technology by pairing a balloon-in-backet catheter with Abbott’s EnSite X EP System heart mapping solution.
“The unique basket shape of the catheter's energy delivery area paired with the balloon are designed to effectively transfer Abbott's optimized waveform energy to the tissue by ensuring better catheter contact and stability during the procedure,” according to an Abbott press release. “Another unique feature of Abbott's PFA catheter is how the platform's PFA generator and the EnSite X EP System are designed to give physicians the ability to specifically target lesions and ablate the exact area(s) of the heart that are triggering arrhythmia.”
The global FocalFlex PFA study is also now underway to assess the TactiFlex Duo Ablation Catheter, SE, which is designed as a dual-energy ablation system offering both PFA and RF energy delivery. “Where the Volt PFA System is designed as a ‘single shot’ PFA approach, the TactiFlex Duo Ablation Catheter, SE is a ‘focal’ or ‘point-by-point’ approach that aims to deliver the safety and efficiency of PFA with more flexible and focused energy,” according to the release. “Designed on Abbott's TactiFlex Ablation Catheter, Sensor Enabled, known for its stability during procedures due to its novel flexible tip, the TactiFlex Duo Ablation Catheter, SE aims to offer physicians another option for delivering PFA and/or RF to patients with greater versatility to precisely target specific areas of tissue within the heart.”
The TactiFlex Duo Ablation Catheter, SE will be assessed in the company’s upcoming FlexPulse IDE study, which is expected to be launched in the US soon and will include about 200 patients at 25 sites, according to Abbott.
In conjunction with the study news, Abbott also announced the FDA clearance of its Advisor HD Grid X Mapping Catheter, SE, that has “first-of-its-kind” electrode configuration for high-density heart mapping, which, according to the company, is “intended to make physicians more aware of electrical signals of the heart, regardless of catheter placement during an ablation procedure.”
As it is, Abbott is betting big on PFA development, and, according to Robert Ford, Abbott CEO, the market is receptive.
“RF catheters, similar to what we saw in the last call, [are] still being used in about 20% of the PFA cases,” Ford said, in the company’s Q2 2024 earning call. “I think the net effect of all of this is the market’s growing, it’s accelerating. We’ve got a strong position. Everything that we’ve talked about in the past, about our opportunity with the mapping and all of the other consumables is there. RF still plays a role, it’s still an important role, and our business has actually grown faster than what it was growing before. If you look at [2019], we were about 12%, [2018] was about 14%, so we’re actually doing better now.”
And based on the company’s recently announced milestones, it seems the investment may pay off.
“I think that is positive for the market, which is why we’ve invested heavily in our PFA portfolio, which will — you will start to see hit the market in the — I’d say next year, I’m not going to try and time the quarter here, but definitely next year,” Ford said. “I think this is good and the teams have done an incredible job at executing the strategy that we laid out, so kudos to them.”
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