Johnson & Johnson Completes Enrollment in Pivotal Omny-IRE Trial for Next-Gen PFA Ablation Platform Omnypulse

Sep 03, 2024 19:09 CST Updated 19:09

Johnson & Johnson

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Source: Heart Future; Editor: Sophia

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Recently,Johnson & Johnson (NYSE: JNJ)Announcing itsNew PFA ProductOmnypulse Completion of enrollment for the clinical study (Omny-IRE).Omny-IRE It is a prospective, multi-center, non-randomized clinical trial that enrolled 188 patients in Europe and Canada.Evaluate Omnypulse TherapySymptomatic Paroxysmal Atrial FibrillationSafety and Effectiveness。

In the PFA market,Boston Scientific(Boston Scientific) andMedtronic(Medtronic) is in a leading position,These two companies are expected to capture 60% of the atrial fibrillation market.，Johnson & Johnson Aims to Seize a Share of Emerging OpportunitiesPreviously, Johnson & Johnson's pursuit of the PFA opportunity has been focused onVaripulse Catheter and Thermocool Smarttouch SF Dual-Energy DeviceAbove. Related Reading:Applying for FDA! Johnson & Johnson's First Pulsed Field Ablation Product

Now, the company through its subsidiary Biosense Webster,Initiate the clinical development of another research device. Same as Varipulse,Omnypulse CatheterReceive pulses from the Johnson & Johnson Trupulse generator and integrate with Johnson & Johnson's most advanced three-dimensional mapping system, the Carto 3 system, to support mapping.Combining the capabilities of large-area ablation and high-density mapping。

The Omny-IRE study aims to evaluateThe safety and effectiveness of the OMNYPULSE™ platform in mapping and treating symptomatic paroxysmal atrial fibrillation (AFib) during standard ablation procedures, while also evaluating the incidence of primary adverse events within 7 days post-operation.

M.D., Ph.D., Department of Electrophysiology, Department of Cardiology, Arizona Hospital, Bruges, BelgiumMattias Duytschaever Indicates:

"In the Omny-IRE trial I participated in, contact force data from the Omnypulse catheter helped create the initial electrogram in the Carto 3 system, and the integrated PF index module allowed me to correlate ablation parameters with lesion processing."The system has the potential for multifunctionality and personalization, which is highly significant for patients.。”

The company stated that by using pulsed electric field ablation during the irreversible electroporation (IRE) process（PFA），Can reduce the risk of damage to surrounding tissues, including esophageal, pulmonary venous, and phrenic nerve injuries.

# Omnypulse Platform

▲ Omnypulse Ablation Catheter

Biosense Webster's Omnypulse platform includes: Omnypulse catheter and Trupulse generator.The Omnypulse catheter is aAblation catheter with a diameter of 7.5Fr and adjustable bending, whose distal end adoptsExpandable Mesh Basket Design, which can be expanded up to 12mm at maximum., which allows it to meet the needs of different areas within the heart.The distal basket of the catheter consists of six splines, each with 2 electrodes distributed on it.

In addition to its design differing from traditional catheters, the Omnipulse also featuresHaptic Feedback and Enhanced Mapping Functionality（TRUEref）。Haptic FeedbackHelps ensure the quality of contact between the catheter and heart tissue during surgery, thusImprove the safety and effectiveness of the surgery；TRUEref Enable the catheter to have higher precision and detailed mapping capabilities,Can reduce the impact of far-field unipolar signals and improve signal quality.。

During the cardiac ablation procedure, the Tripulse generator delivers energy to the catheter's 12 electrodes.Bipolar, Biphasic Pulse SequencePreviously, Trupulse also provided pulse energy for the Varipulse pulsed ablation catheter and the dual-energy ablation catheter Thermocool Smarttouch SF.Is the foundation of Johnson & Johnson's PFA ablation technology。

The goal of the OmnyPulse platform isAchieving Atrial Fibrillation Treatment Through a Single Device, which combines the ability of large-area ablation and creating high-density electrocardiograms.

# Fierce Market Competition

Technically speaking,Johnson & Johnson's Omnypulse is对标的就是Medtronic's Sphere-9 Ablation Catheter。

Sphere-9 is also a7.5Fr Bidirectional Adjustable Catheter, with an inflatable conductive lattice electrode. The catheter is inserted into the sheath in a folded form, and once inside the heart, the lattice expands into a spherical structure with a diameter of 9 millimeters. Nine miniature electrodes/temperature sensors, each with a diameter of 0.7 millimeters, are evenly distributed across the lattice surface.Sphere-9 combines mapping, navigation, and therapeutic functions, and isCurrently the onlyCatheter capable of delivering radiofrequency and electrical pulses for ablation, allowing doctors to tailor treatment plans according to patient needs during the ablation process.

▲ Sphere-9 Ablation Catheter

Of course, dual-energy ablation is not very difficult for Johnson & Johnson.Johnson & Johnson has already achieved dual-energy ablation on the Thermocool Smarttouch SF, and only needs to equip Omnypulse with a radiofrequency energy platform to achieve dual-energy ablation.

In addition, Medtronic has a PFA catheter called Sphere360, which is considered to truly achieve one-time complete ablation.Sphere360 is a new type of 7F online multi-segment grid spherical catheter., the distal end of the catheter is a spherical electrode containing 34 lattices, capable of delivering electrical pulse energy uniformly and efficiently. The shape of the electrode can be adjusted according to the patient's physiological structure, thereby better conforming to various pulmonary vein anatomical structures.Can be integrated with the Affera mapping and ablation system to achieve low to zero fluoroscopy.Medtronic announced clinical research results about the catheter at the 2024 European Heart Rhythm Association meeting.Showing positive results for both safety and efficacy.。

Boston Scientific is the pioneer of PFA, and itsFarapulse isThe World's First Commercially Launched PFA Product, which gives Boston Scientific an edge over strong competitors like Johnson & Johnson and Medtronic.Currently, the Farapulse PFA product is indicated for drug-resistant, recurrent, symptomatic, paroxysmal atrial fibrillation.To expand the indications, Boston Scientific has initiated the AVANT GUARD clinical trial recruitment.To conduct research on PFA therapy as a first-line treatment for persistent atrial fibrillation, comparing its safety and efficacy with antiarrhythmic drug therapy.

In addition,Boston Scientific Plans to Approve Farapoint Catheter in 2025, Launch New Farawave Nav Catheter by End of 2024, and Integrate Rhythmia Mapping System with Faraview Software。

Compared with the aforementioned three,Abbott's Speed in PFA is SlowerIn March 2024, Abbott initiated the IDE clinical study for its PFA product, Volt. Abbott considers Volt as a second-generation PFA product, which, compared to other products,Achieve pulmonary vein isolation with just one ablation.。The biggest difference between Volt PFA and the first-generation PFA lies inThe distal end of its ablation catheter is a balloon., and attach 8 ablation band electrodes to the balloon,Can closely conform to the pulmonary vein vestibule, thereby achieving more precise ablation.

Abbott has also designed unique positioning, operation, and steering for the Volt PFA catheter, providing doctors with clearer guidance.Further improve contact with the target cardiac tissue, whose balloon function can effectively transfer energy to the tissue, thereby improving the way the catheter creates lesions and blocking unstable signals in the heart.Volt PFA Can Be Used with Abbott’s EnSite X EP 3D Mapping SystemEnSite X EP can guide doctors to accurately identify areas of the heart that require ablation, allowing the Volt PFA catheter to be positioned and treat more precisely.

Apart from foreign markets, the vast market space and development potential in China also attract the attention of giants. The successful launch of Boston Scientific's PFA product in China marks its gaining of a first-mover advantage in the competition among giants.But this does not mean we can rest easy,Medtronic and Johnson & Johnson's PFA products have also entered the NMPA Innovative Medical Device Special Review Process, and their approval is imminent.。

In addition,These electrophysiology giants are also facing pressure from China's local innovative forces.。PFA Products from Jinjiang Electronics and Denovo Electrophysiology Have Been Approved for Marketing, Northcore Medical's PFA product has also entered the NMPA review process. Other companies such as Xuanyu Medical, Aikangmai Medical, Xin Lvtong, Zhoulǐng Medical, and Yuanshan Medical have also entered the market, with PFA products from Huital Medical, Micro EP, and Maiwei Medical already in various stages of clinical trials.

It can be foreseen that the PFA market in China will face fierce market competition in the future, not onlyThe market share of domestically produced products in the electrophysiology market is expected to increase, andUnder the balance of power among various parties, patients in urgent need of treatment have also become the biggest beneficiaries.

Editor-in-Chief | Zhao Qing Reviewed by | Yi He