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Medtronic Makes a Double Play for Atrial Fibrillation

Medtronic scored CE marks for its pulsed field ablation and cryoablation console devices to treat atrial fibrillation.

By Amanda Pedersen

Medtronic scored a double CE mark win for its PulseSelect pulsed field ablation (PFA) system, designed to treat atrial fibrillation,?and the Nitron CryoConsole, designed to optimize workflow for cryoballoon ablation.

The PulseSelect system follows the company's CE mark in March for the Affera mapping and ablation system and sets?Medtronic apart in the increasingly competitive PFA market.

"We are now the only company with approved catheters for both single shot and focal PFA," Medtronic CEO Geoff Martha said during the company's earnings call earlier this week.

Medtronic expects to launch the PulseSelect system in Europe early in 2024. Martha noted that FDA is currently reviewing the company's PulseSelect submission, and the company anticipates being among the first with a PFA catheter in the U.S. market.

Pulsed?field ablation?has been?touted?as a?promising new ablation modality for the treatment of atrial fibrillation. This ablation method?is intended to ablate heart tissue via the creation of a therapeutic electric field?instead of using thermal energy sources such as radiofrequency ablation or cryoablation.

PulseSelect uses a non-thermal approach to preferentially target the pulmonary veins for ablation, avoiding unwanted injury to surrounding structures, which is a risk of current ablation technologies (thermal energy sources). The catheter utilizes a biphasic waveform, a built-in over-the-wire design and 20-degree forward tilt to support procedural maneuverability, reliability, and safety, as demonstrated by the PULSED AF trial. Based on data from the?trial, the catheter has demonstrated efficient pulmonary vein isolation with an average of 30 seconds of total energy delivery time to isolate all veins.

“The electrophysiology community is eagerly awaiting new innovation to enhance the safety and efficiency of [atrial fibrillation] ablation. PulseSelect is specifically engineered to deliver pulsed field energy safely and maneuvers well, with great overall control of the energy applications,” said Lucas V.A. Boersma, MD, PhD, a cardiologist at St. Antonius Hospital in Nieuwegein, The Netherlands, and a professor of cardiology at?Amsterdam University Medical Centers, University of Amsterdam, The Netherlands. “The safety profile shown by the PulseSelect system in its global pivotal study is one of the best compared to today’s standard of care for catheter ablation technologies.”

The PulseSelect system is designed as a plug-and-play system, meaning it can be used with any mapping system or with fluoroscopy. As an added safety feature, the design also includes a phrenic nerve test pulse, which acts as a non-therapeutic low voltage pulse that provides a preemptive assessment of catheter proximity to the phrenic nerve before delivering a therapeutic application. The?design also features?fixed spacing for the nine-electrode catheter produces a predictable and consistent electric field for contiguous ablation.

Medtronic counts its cardiac ablation solutions business among its highest growth markets.

"Over the coming years, we expect this business to be a very meaningful growth driver for Medtronic," Martha said.

The race for pulsed field ablation market share is intense

Treating AF with ablation (electrophysiology/EP) is an $8 billion market with a long runway, according to Travis Steed, a medtech analyst at Bank of America. Steed estimates that only about 15% of the eligible 2.5 million U.S. patients with AF are currently being treated with ablation (worldwide, around 650,000 ablations versus 35 million patients with AF, he notes).

So, it's no wonder?Medtronic, Johnson & Johnson, and Boston Scientific are all jockeying for market share in pulsed field ablation. There are also several private companies developing PFA technology.

In a February 24 report, Steed wrote that pulsed field ablation looks to be safer and faster and could potentially revolutionize the way ablations are done today and expand the market. The key question comes down to data, as?PFA must continue to prove durability and safety in line with thermal-based options such as?radiofrequency ablation?or?cryoablation,?the analyst noted.

"Our doc conversations suggest that physicians want to see data on each platform as all PFA systems are not created equal," Steed wrote.

Stratasys, Siemens Healthineers Partner for Medical Imaging Phantom Research Project

The study’s phase one endpoint will be the 3D-printing of a heart model and a model of an entire human torso with complete radiographic accuracy.

By Katie Hobbins

Stratasys, a medtech company focused on polymer 3D-printing and additive manufacturing, and Siemens Healthineers, have partnered for a landmark research project designed to develop new state-of-the-art solutions for the advancement of medical imaging phantoms for CT imaging.

“The current limitations of imaging phantoms have been a longstanding challenge for the radiology community,” said Erez Ben Zvi, vice president medical at Stratasys, in the press release. “This partnership with Siemens Healthineers will enable us to jointly explore the vast possibilities of our radiopaque materials and 3D-printing technologies to overcome these barriers.”

CT phantoms are categorized as specialized devices used to evaluate and ensure the performance of CT scanners. They are designed to simulate certain characteristics of the human body, enabling the assessment of various core metrics, including radiation dose, image quality, calibration, and consistent scanner performance, according to Stratasys.

The research project will combine Stratasys’ PolyJet technology with its RadioMatrix technology, and Siemens advanced algorithm to translate scanned patient images “into specific material characteristics with radiopacity of human anatomy,” according to the press release announcing the partnership. “The solution will allow for tailored phantom manufacturing and the creation of ultra-realistic human anatomy characteristics with complete radiographic accuracy of patient-specific pathology not previously possible.”

Starting with the manufacturing of 3D-printed phantoms for smaller-scale anatomies, like of the head and neck region, the research will then progressively produce larger and more complex structures. This will lead to study’s phase one endpoint of 3D-printing a heart model and a model of an entire human torso with complete radiographic accuracy.

The joint project, according to the companies, will “transform how phantoms can be utilized in the medical field, and in certain cases even enable device manufacturers and academic facilities to replace human cadavers with 3D-printed structures. Having this capability enables critical efficiencies and minimizes inevitable human variability. This work will also produce a critical body of research data, providing key insights for advancing CT system algorithms, driving materials development, and unlocking potential new application areas — as well as identifying future research opportunities.”

This Disappearing Heart Device Disappeared Altogether

What cardiovascular device did Abbott pull from the market just a little more than a year after winning FDA approval?

By Amanda Pedersen

Abbott was the first company to bring a drug-eluting bioresorbable vascular scaffold (BVS) to market, having received?a CE mark for its Absorb BVS in January 2011 and FDA approval in July 2016.

But the Absorb BVS never enjoyed widespread adoption and?clinical data on the device was mixed. The device was also the subject of an FDA safety alert in March 2017 linking Absorb to a higher rate of major adverse cardiac events. So, it wasn't a complete surprise when,?little more than a year after FDA approval, Abbott decided to take the Absorb BVS off the market.

The structure of the Absorb GT1?BVS was made of poly(L-lactide), a biodegradable polymer that dissolves over about three years, leaving the patient's artery free of permanent implants except for four tiny platinum markers in the artery walls denoting placement.

Abbott's CEO at the time, Miles White, described Absorb as a "very niche product," and he noted that physicians were more interested in a more deliverable stent than they were a bioabsorbable coated stent. So, the company turned its attention to the Xience Sierra, a follow-up to its Xience drug-eluting stent. The Sierra drug-eluting stent offered more sizes, better deliverability, and improved imaging tools.

A company spokesperson told MD+DI at the time that Abbott would incorporate learnings from Absorb into a second-generation bioresorbable technology with a smaller profile and improved deliverability to reduce implantation time. However, not much news has emerged on the project since then.

That said, a researcher from the Icahn School of Medicine at Mount Sinai did report significant findings earlier this year from a global trial that could lead to?advancements and improvements in new BVS technology and future clinical use among interventional cardiologists across the United States.

The?multi-center trial examined the long-term safety and effectiveness of percutaneous coronary intervention?using the Absorb BVS. Five-year results from the ABSORB IV trial were presented in May at the EuroPCR meeting in Paris and published in the?Journal of the American College of Cardiology.

The study showed that Absorb, when implanted with optimal technique, resulted in?similar five-year rates of patient-oriented adverse events, quality of life, and recurrent angina as the standard metallic drug-eluting stent,?according to lead author Gregg W. Stone, MD, director of academic affairs for the Mount Sinai Health System and a cardiology professor?at Icahn Mount Sinai. Stone acknowledged that some adverse events were more common within the first three years, prior to the scaffold's complete bioresorption. Thereafter, he said, event rates were nearly identical with BVS and metallic stents.

"The early excess risk could likely be eliminated with an improved thinner next-generation scaffold and its implantation with intravascular imaging guidance, affording long-term restoration of the coronary artery to its original native state without a permanent implant," Stone said. "There is a real desire among patients and their doctors for an absorbable stent which is present early while it is needed and then completely disappears. The favorable long-term results from this study emphasize the fact that this novel technology, which was voluntarily withdrawn from the market by the manufacturer due to lower than expected market adoption, should not be abandoned.”

Masimo Nabs W1 Medical Watch Clearance After ITC Order potential ban of Apple Watch Imports

The order to bar the import of Apple Watches won’t take immediate effect as it still faces presidential review and possible appeals.

By Katie Hobbins

Masimo recently announced that the Masimo W1 medical watch has received FDA 510(k) clearance for both over-the-counter (OTC) and prescription use, expanding indication for the device in the United States to use by adults in hospitals, clinics, long-term care facilities, and at home.

The W1 integrates its MW1-1 sensor, hardware, and software module pulse oximetry knowledge into a single wearable. The watch includes an optical sensor and electrocardiogram electrode pads which can detect physiological signals. The MW1 processes these signals using the company’s proprietary signal processing algorithms to output “high resolution SpO2, PR, perfusion index (Pi), and heart rate from an ECG,” according to Masimo. Continuous data from the module is displayed in real-time on the watch touchscreen and helps identify low oxygen saturation, high pulse rate, or low pulse rate by showing SpO2 and PR values in red.

“Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in a variety of innovative ways,” said Joe Kiani, founder and CEO of Masimo, in the press release announcing the approval. “For example, Cambridge University Hospitals in England is using it to expand their Virtual Health program to support more confident patient discharge. The Department of Anesthesiology at CHUV in Lausanne, Switzerland is using Masimo W1 on preoperative patients, to help anesthesiologists better understand the physiology and areas to improve for each patient they care for in the hospital, prior to surgery. We are excited about the hospital-to-home innovations the Masimo W1 can bring to the US, with this FDA clearance, and the empowerment of patients at home.”

The clearance comes after the US International Trade Commission (ITC) issued an order to Apple at the end of October which could bar the tech giant from importing its Apple Watches. The decision is due to a court ruling, which was upheld at the beginning of the year, that found Apple had violated Masimo’s rights in light-based technology for reading blood-oxygen levels. Masimo alleged that the company stole its intellectual property and incorporated it in several Apple Watch models.

The decision will not go into immediate effect as it now faces presidential review and possible appeals. The Biden Administration has 60 days to decide whether to veto the import ban based on policy concerns. Of note, presidents have rarely vetoed bans in the past. Additionally, Apple has the opportunity to appeal the ban in the US Court of Appeals for the Federal Circuit after the review period ends.

Along with Apple and Masimo’s legal fight, there continues to be ongoing pushback to further inform the public of long-standing worries connected to the accuracy of pulse oximetry dependent on skin tone differences. Recently, 25 attorney generals came together in a letter to the FDA to “encourage the FDA to act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin.”

They wrote that since FDA convened an advisory committee in 2022 to discuss mounting evidence from real-word studies that suggest performance of pulse oximeters can be affected by skin pigmentation, devices have continued to be sold “without clear warning labels or other guidance to protect individuals from harm.”

The letter called on the administration to immediately take six actions to ensure the safety and effectiveness of the device, MD+DI previously reported. “As you know, regulation of medical devices such as pulse oximeters, including their ‘safety and effectiveness,’ is the responsibility of the FDA 21 U.S.C. § 360k(a),” according to the letter. “We therefore respectfully ask the FDA to take immediate action to ameliorate further unnecessary health risk to people with darker skin tones.”

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