The global cardiac rhythm management (CRM) device market was valued at $16.9 billion last year, according to Grand View Research. Increases in heart failure and arrhythmia incidence have fueled demand for advanced CRM devices. Further, photoplethysmography technology in fitness trackers and smartwatches can boost atrial fibrillation (AFib) detection and screening.

The COVID-19 pandemic unfortunately slowed the CRM market’s beat. Medtronic reported a 12 percent decrease in its CRM device segment from 2019 to 2020. The decline mainly affected implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy devices (CRT-Ds), and pacemakers. The overall market declined 6.1 percent in 2020, and CRM giants Abbott and Boston Scientific Corp. witnessed a decline of 10.7 percent and 12.1 percent respectively in their cardiac rhythm and heart failure segments last year.

The defibrillator segment dominated the CRM industry, holding 43.5 percent revenue share last year. Rising adoption of subcutaneous implantable defibrillators and transvenous ICDs provoked this healthy market share. The global CRM market, according to Grand View, is anticipated to grow at a 7.4 percent compound annual growth rate to reach $29.9 billion in 2028—provided the segment rebounds quickly from COVID-19’s squeeze.

Following are examinations of how several leading medical device makers are innovating in the field of cardiac rhythm management.

Abbott Laboratories
Multi-faceted medical device maker Abbott Laboratories has a large cardiovascular device portfolio. The arsenal includes treatments and therapies for cardiac arrhythmias, coronary artery disease, heart failure, and heart valve disease. Its rhythm management line offers cardiac ablation, cardiac monitoring, implantable cardioverter defibrillators (ICDs), cardiac resychronization therapy debrillators (CRT-Ds), and pacemakers.

Abbott initially acquired the Gallant ICD and cardiac CRT-D devices from former multibillion dollar device maker St. Jude Medical Inc. The latest generation of these devices earned CE mark approval last February, and FDA approval last July. They feature good battery longevity and MRI compatibility, as well as Bluetooth technology and a new smartphone app to boost remote monitoring.

The system pairs with the iOS- and Android-compatible mobile smartphone app myMerlinPulse to streamline communication between clinicians and patients. The app allows users to access data, device performance, and transmission history so patients can be more active in their healthcare. Physicians can continuously monitor patients, remotely allowing identification of asymptomatic episodes and patient-triggered transmissions. This can lead to earlier intervention and minimize clinical burden.

“Remote monitoring isn’t a new concept, but recently we’ve seen this technology’s demand and acceptance grow,” said Vish Charan, divisional vice president, Product Development, Cardiac Rhythm Management, at Abbott Laboratories. “We focus on innovative connectivity solutions for our cardiac devices that provide physicians with the quick and accurate information needed to better assess and treat their patients. Remote monitoring solutions, like our Gallant ICD and CRT-D devices, which offer Bluetooth connectivity and pair with the myMerlinPulse app, fit seamlessly into people’s lives and encourage compliance—resulting in better outcomes and higher engagement.”

An insertable cardiac monitor (ICM) is a small device programmed to continuously monitor cardiac activities before, during, and after episodes of possible cardiac conditions including recurrent unexplained fainting, heart palpitations, unexplained stroke, and atrial fibrillation. The ICM then records cardiac rhythms automatically and manually through use of a handheld patient assistant. With this in-depth and real-time data, clinicians can better analyze heart conditions and determine the cause. The procedure to insert an ICM is usually brief and minimally invasive, the tiny and powerful system inserted just beneath the skin of the chest.

Abbott Laboratories’ Confirm Rx ICM gained CE mark approval in May 2017, earning it the title of the world’s first smartphone-compatible ICM. It works with the myMerlin mobile app so clinicians can remotely follow patients and diagnose arrhythmias. FDA 510(k) clearance soon followed in October of that year. The latest generation Confirm Dx ICM with more accurate arrhythmia detection came in May 2019.

Abbott’s Jot Dx ICM hit the U.S. market this past July. The flow of information gathered by Jot Dx can be managed via a feature to view either all abnormal heart rhythm data or simplify which irregular heart rhythms are recorded with a “key episodes” option. Clinicians can toggle between viewing only three key episodes or all episodes depending on patient needs to make an accurate diagnosis. This reduces overall data burden, potentially saving clinic staff up to 120 hours a month in reviewing electromyogram transmissions.

“We brought to the market the first always connected, paperclip-sized cardiac monitor (Confirm Rx and now Jot Dx), and the next generation of connected devices with our Gallant ICD and CRT-D, and iOS and Android based apps for enhanced remote monitoring of cardiac devices,” said Charan. “We continue to focus on innovative patient-centric solutions involving connected technologies and miniaturization of cardiac devices.”

Boston Scientific
Boston Scientific also touts a healthy mix of cardiovascular devices, including technology for electrophysiology, interventional cardiology, structural heart, and vascular surgery. Rhythm management options include ICMs, ICDs, CRT-Ds, mapping, and remote cardiac patient management.

The company had invested in pulsed field ablation (PFA) device maker Farapulse since 2014. The relatively new ablation modality is used to treat atrial fibrillation (AFib) through a train of microsecond high amplitude electrical pulses that ablate myocardium via electroporation of the sarcolemmal membrane without measurable tissue heating. In June, Boston Scientific acquired the remaining 73 percent stake not yet owned for about $295 million.

Farapulse was the first company to bring a cardiac PFA technology to market following CE mark approval in the first quarter of this year. This past March, the company began its pivotal IDE (ADVENT) trial with over 100 patients enrolled. It compared the Farapulse PFA system to standard-of-care ablation in patients with paroxysmal AFib with a primary endpoint of AFib freedom at 12 months after one ablation procedure.

“The electrophysiology field is one of our largest and fastest growing markets,” said Dr. Kenneth Stein, senior vice president and chief medical officer, Rhythm Management and Global Health Policy at Boston Scientific.

“We acquired Farapulse, who is pioneering the PFA field. We believe the emerging technology of PFA can alter the future of ablation therapy for atrial fibrillation and other cardiac arrhythmias with improvements in both safety and procedural efficiency. This technology will enable us to be the only company to offer a comprehensive set of electrophysiology solutions to physicians—including radiofrequency ablation, cryoablation, and now PFA—so they can select a therapeutic option based on clinical preference and individualized patient needs.”

Around the same time, Boston Scientific welcomed cardiac arrhythmia mobile health solutions and remote monitoring firm Preventice Solutions for $925 million up front and up to $300 million in potential commercial milestone payments. Products gained include wearables like the PatientCare and BodyGuardian family of monitors.

BodyGuardian monitors feature an integrated, cloud-based platform and AI algorithms for insights that lead to improved diagnoses and outcomes. The newest BodyGuardian Mini Plus touts various electrode options to boost rhythm detection, is waterproof and repositionable, and can be used in all short- and long-term monitoring modalities as determined by physicians. The BeatLogic AI algorithms detect, classify, and interpret heart rhythm data variations with high beat detection sensitivity and positive predictive value.

“Cardiovascular disease is the leading cause of mortality globally, highlighting the need for early detection and management of individuals who may be at risk of a cardiac event,” said Dr. Stein. “We recently acquired Preventice Solutions, supporting our efforts to lead in the cardiac diagnostics and services space. Preventice offers a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors to cardiac event monitors and mobile cardiac telemetry. Physicians may ask at-risk patients to wear an external cardiac monitor to assess how their heart is functioning, which may lead to an arryhthmia diagnosis, and the recordings taken by the monitor can help physicians develop an optimal and personalized treatment plan. This integration of artificial intelligence and human expertise can enhance physician efficiency and the patient experience, which is especially exciting.”

Boston Scientific nabbed FDA clearance for the LUX-Dx ICM in June 2020. Its dual-stage algorithm spots and verifies potential arrhythmias before sending an alert to offer actionable data for clinical decision-making. It has remote programming capabilities so physicians and care teams can adjust event detection settings without an in-patient appointment. The dual-stage algorithm can be programmed to identify various cardiac episodes.

“We launched our LUX-Dx ICM in late 2020, a long-term diagnostic device implanted to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope,” said Dr. Stein. “We’ve been encouraged by the strength of physician feedback in terms of implant experience, p-wave detection, ECG quality, and our remote programming capability. This is truly a next-generation device.”

The company’s MultiSite pacing was evaluated for safety and effectiveness in initial non-responders to conventional cardiac resychronization therapy (CRT), with the goal to increase response to CRT. Multi-site pacing has been debated as an alternative to single site pacing for years and the trial offered additional data to support it.

“We also presented late-breaking data at Heart Rhythm 2021, demonstrating MultiSite pacing—a feature on our RESONATE X4 defibrillators—is safe and effective when used in non-responders to traditional CRT, with minimal impact to device battery life,” said Dr. Stein. “MultiSite pacing enables simultaneous pacing from distinct locations in the left ventricle, providing additional options for non-responders.”

In the study, patients who didn’t respond had the multi-site pacing feature turned on, resulting in 51 percent of the non-responders to respond to therapy.

Medtronic
It would be remiss not to highlight medtech behemoth (and MPO Top 30 leader) Medtronic plc’s collection of cardiac rhythm management devices, as its portfolio is possibly the most extensive of the lot.

The firm achieved FDA approval last November for the Micra AV leadless pacemaker for patients with atrioventricular (AV) block—when the electrical signals between heart chambers are impaired. Patients with AV block were historically treated with dual-chamber pacemakers. Micra AV contains internal atrial sensing algorithms to detect cardiac movement so the device can adjust ventricle pacing to coordinate with the atrium for “AV synchronous” pacing therapy. The company’s MARVEL 2 study met efficacy objectives with a greater number of AV block patients with normal sinus rhythm experiencing greater than 70 percent AV synchrony during AV synchronous pacing.

This past August, Medtronic released data from the Micra Coverage with Development study, the largest leadless pacemaker evaluation to date. Data showed 38 perfect reduction in reinterventions and 31 percent reduction in chronic complications for patients implanted with Micra at two years compared to traditional pacemakers.

“The results from this study further support the connection of a lower risk of complications with leadless pacing compared with traditional transvenous single chamber pacing,” Jonathan P. Piccini, M.D., associate professor of medicine and director of cardiac electrophysiology at Duke University Medical Center, told the press. “These data should help guide physicians as they determine the best pacing options for their patients."

The LINQ II ICM with remote programming earned FDA and EU nods last July. About one-third the size of a AAA battery, the wireless ICM spots abnormal heart rhythms for patients who experience infrequent symptoms. The device became commercially available later that summer.

The LINQ II ICM, according to Medtronic, has the lowest published rate of AFib false detections compared to previous ICMs. It features a premature ventricular contraction (PVC) detector to assist diagnosis. Study data also showed physicians spent 33 percent less time reviewing ICM transmissions. It boasts remote programming and patient management with a companion MyCareLink Heart mobile app. According to the firm, the device has a 4.5-year continuous monitoring duration.

“In the current COVID-19 environment, the LINQ II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits,” Rob Kowal, M.D., Ph.D., chief medical officer of Medtronic’s Cardiac Rhythm and Heart Failure division, told the press.

Clinical trial results from the company’s STROKE AF trial released this past June affirmed the Reveal LINQ ICM’s utility in spotting AFib in large and small vessel stroke patients compared to standard of care. Of the 496 patients evaluated, after one year AFib was spotted in 12.1 percent of ICM patients compared to 1.8 percent receiving standard of care. Seventy-eight percent of patients who experienced AFib would have been missed if only monitored for 30 days, Medtronic claimed. Median AFib detection time was 99 days.

"Preventing recurrent stroke is challenging,” Lee H. Schwamm, M.D., vice president of Virtual Care and Digital Health, Mass General Brigham and C. Miller Fisher chair in Vascular Neurology, Massachusetts General Hospital, commented to the press. “I believe the findings from the STROKE AF study strongly suggest the need to re-examine the role of ICMs in secondary prevention, go beyond just the cryptogenic stroke patient, and embrace a broader conceptual framework that shifts the emphasis away from the cause of the index stroke and onto future stroke prevention."

A month later the firm earned FDA clearance for two AccuRhythm AI algorithms for the LINQ II ICM. These algorithms apply AI to heart rhythm event data to improve the accuracy of information physicians gather for more effective diagnosis and treatment. The algorithms address AFib and asystole (long pause between heartbeats), the two most common ICM false alerts. Medtronic data presented at Heart Rhythm 2021 showed the AFib algorithm reduced LINQ II ICM false alerts by 74.1 percent and preserved 99.3 percent of true alerts. The Pause algorithm reduced false pause alerts by 97.4 percent and preserved all true pause alerts. The AccuRhythm AI platform and initial algorithms were developed using Medtronic’s proprietary, diverse, and debiased database of over 1 million ECG heart rhythm episodes.

The Supply Side
Rapid production of innovative cardiovascular monitoring, diagnostic, and therapeutic technologies would not be possible without partners that specialize in manufacturing them or their components. So in order to gather insight on what these specialized manufacturing partners are capable of and how they assist the cardiovascular device industry, Medical Product Outsourcing spoke with two experts over the past few weeks:

Ryan Balko, business unit director, design and development at Nordson Medical, a Minneapolis, Minn.-based designer, developer, and manufacturer of complex medical devices and component technologies.

Daniel Morales, applications engineer at MicroLumen, an Oldsmar, Fla.-based manufacturer of high-performance medical and surgical tubing.

Sam Brusco: What types of cardiovascular procedures/devices are your products used in, and how do they benefit clinicians/medical device manufacturers?

Ryan Balko: Nordson produces a wide variety of critical components, sub-assemblies, and finished devices necessary to support numerous procedures covering neurovascular, structural heart, endovascular, and peripheral vascular. The products we produce enhance the standard of living and ultimately save lives for patients globally.

The cardiovascular disease market is growing steadily due to an increasing prevalence of chronic diseases like diabetes. There are innovative new drugs and devices that lead to less-invasive treatment options. In particular, cardiovascular catheters are leveraging improved imaging and robotic-assisted surgeries. These devices require high strength and flexibility to effectively navigate the vasculature.

We are a full-service provider of balloon catheters commonly used to treat cardiovascular disease. Our Catheter Center of Excellence builds on our decades-long expertise in complex components including heat shrink tubing, complex medical balloons, and polytetrafluoroethylene (PTFE) liner tubing. Following are procedures these products are used in.

Balloon occlusion—A balloon occlusion test is performed to determine if there is an aneurysm or tumor in one of the four main arteries that supply blood to your brain. Under X-ray, a special dye is used, as a small balloon is inflated to temporarily block an artery, to determine how well blood is moving.

Balloon angioplasty—Also known as percutaneous transluminal coronary angioplasty (PTCA), a minimally-invasive procedure widens or opens narrowed or blocked arteries. A small balloon catheter is placed through the femoral artery, and the balloon is inflated to compress plaque against the artery wall. Then a stent can be placed to keep the artery open.

Atherectomy—A procedure that uses a catheter to clean clogged arteries. The catheter is designed to collect the plaque and remove it from the artery.

Hypothermic cooling—Used after cardiac arrest to lower the body temperature to around 90°F to reduce damage to the brain and increase chance of survival.

Extracorporeal life support—A type of cardiopulmonary bypass that maintains oxygenation to the heart, lung, or both for up to several weeks.

Our products that serve in cardiovascular procedures include balloon catheters, cannulae, medical balloons, heat shrink tubing, PTFE liners, engineered shafts, polyimide tubing, complex extruded tubing, nitinol components, and fluid management components.

Daniel Morales: MicroLumen is a manufacturer of high performance medical and surgical tubing. Our primary materials are polyimide, PTFE, polyurethane, Pebax and nylon. Our medical tubing provides excellent mechanical, thermal, and chemical properties with tighter tolerances than conventionally extruded plastic tubing.

We also have the capability to produce sub-assemblies, reducing the number of suppliers device manufacturers may need and can decrease the lead time in which product can be developed and launched to market. Sub-assemblies and composite tubing allow us to provide the multi-functionality a customer would want in a minimally invasive product, providing exceptional consistency in product performance.

Here are a few examples of applications MicroLumen tubing is used in regarding cardiovascular procedures/devices.

Transcatheter structural heart implant delivery—Complicated delivery systems that require many various working lumens. Often, it’s difficult to streamline the delivery system to manageable diameters so tubing with strong, thin walls is desired for steering wires, fluid lumens and various tools. 

Electrophysiology—Mapping and ablation catheters (Insulator and fluid lumens). Our tubing is often used for dielectric strength and thin walls. Also, left atrial heart procedures often use steerable catheters that use our tubes for pull wire/cable protection and encapsulation.

Procedural devices—Mechanical thrombectomy and atherectomy. Our tubing is often used for thin walls and strength. When removing thrombus or plaque, manufacturers require large lumens and thin walls to remove as much material as possible without using large catheters.