The Beat Goes On in the Cardiovascular Device Market

Contrary to its dictionary definition, “heart failure” doesn’t mean the heart has stopped beating. Heart failure—HF, for short—develops when the heart can’t pump enough blood for the body’s needs. Also called congestive HF, it can also happen if the heart can’t fill up with blood properly or when it’s too weak to pump correctly.

Despite the slight misnomer, HF is extremely serious and demands immediate medical care. It can arise suddenly or gradually as the heart weakens, is often caused by another cardiovascular condition, and can damage the liver and kidneys. It can also lead to cardiac arrest—when the heart actually stops pumping.

As such, catching HF early is crucial to begin treatment before the damage is done: “When equipped with the right tools and understanding of which patients are at risk, physicians can begin treatment early to prevent heart failure from advancing, even when symptoms are mild,” Philip B. Adamson, M.D., chief medical officer of Heart Failure for Abbott Laboratories, told MPO.

Effectively managing HF will also require coordinated care: using technology that better monitors patient information, and lets patients communicate with their care team at a moment’s notice. Connected health devices aim to help doctors meet patients anytime and anyplace when needed.

“Connected health devices that are part of the standard of care for chronic conditions like diabetes are beginning to transform how we treat heart disease, including heart failure,” said Dr. Adamson. “These advancements arm providers and patients with real-time data outside of a clinical setting, improving health outcomes and building stronger connections between care teams and their patients.”

The result is a more preventive, proactive HF management plan.

“Abbott’s connected care technology is building more collaboration between clinical teams and patients, helping to treat heart failure before it worsens,” Dr. Adamson went on. “For example, our CardioMEMS remote-monitoring technology delivers real-time patient data to care teams to enable immediate, informed treatment decisions that can help reduce patient hospitalizations and disease progression.”

The CardioMEMS HF system was first approved by the U.S. Food and Drug Administration (FDA) in 2014 for New York Heart Association (NYHA) Class III HF patients who have been hospitalized for HF in the preceding year and/or have elevated natriuretic peptides. It is a wireless, paperclip-sized sensor placed in the distal pulmonary artery in a catheter-based procedure. It measures and monitors systolic, diastolic, and mean pulmonary artery pressure and heart rate. The hemodynamic data CardioMEMS produces, the company says, aims to control pulmonary artery pressure and keep patients out of the hospital as they manage their condition.

CardioMEMS was granted expanded indication to NYHA Class II (i.e., earlier stage) HF patients in 2022. The hemodynamic data it generates can be collected in the physician’s office, clinic, hospital, or the patient’s home.

“The CardioMEMS HF System can detect pulmonary artery pressure changes that can indicate worsening heart failure—even before the patient starts to physically feel symptoms,” said Dr. Adamson. “The care team can remotely monitor for changes to the patient’s pressure, make immediate therapy adjustments if needed, and watch the effects of those adjustments in real-time. Before this technology, many patients would have required hospitalization.”

The hemodynamic data can be transmitted to a secure website, which serves as a patient database so pulmonary artery monitoring info is available whenever it’s needed via the internet. The pressure changes can be used with HF signs and symptoms to guide medication adjustments.

CardioMEMS is one of several Abbott implants that connects to its Merlin.net Patient Care Network (PCN), a remote follow-up system that imports and manages cardiac information. Clinicians can upload and manage patient device data using a web interface, with only an Internet connection and a compatible browser.

In May, Abbott released new data from MONITOR-HF, its 348-patient European trial that showed a 44% decrease in HF-related hospitalizations for patients using guide-line directed medical therapy. The trial data also demonstrated “clinically meaningful” improvement in patient-reported quality of life scores—a seven-point mean increase on the Kansas City Cardiomyopathy Questionnaire’s (KCCQ) score compared to the control group—as early as three months after using the remote monitoring sensor. The company said it’s the third randomized, controlled trial worldwide to show significant health benefit and quality of life improvement among heart failure patients using CardioMEMS.

Two months earlier, Abbott also shared meta-analysis of three randomized, controlled trials (CHAMPION, GUIDE-HF and LAPTOP-HF) showing 25% reduced mortality risk at two years in patients with HFrEF (heart failure with reduced ejection fraction). Within that analysis, data from the combined trials assessed the mortality and heart failure hospitalizations of 1,350 HFrEF patients. The company said the meta-analysis validated hemodynamic monitoring as a tool to slow the progression of HF.

Apart from just the technology, Abbott and many other device makers offer a range of content to help clinicians learn and discover the latest and greatest HF information and treatments.

“We offer a range of in-person and online education initiatives—including videos, timely podcasts and on-demand webinars—to share the latest research, best practices, and perspectives from leading specialists in the field of heart failure,” Dr. Adamson said.

Dr. Adamson reiterated how crucial it is to make use of the best tools available to combat the ailment that affects about 6.2 million U.S. adults and costs the nation an estimated $30.7 billion every year.¹

“We must educate primary care physicians, nurse practitioners, and other healthcare professionals about the proven clinical benefits of available therapies and new technologies to help improve access for heart failure patients,” he said. “Referring heart failure patients earlier rather than later to a heart failure specialist who can recommend different technologies before their disease advances is also critical to helping patients live longer, fuller lives.”

Heart Parts

Technologies to manage heart failure—while crucial—are but a small sliver of the enormous cardiovascular device market. Encompassed in its vast category are diagnostic, monitoring, therapeutic, and surgical devices, and it’s quite a long list:

• Electrocardiograms (ECG/EKG)
• Holter monitors
• Event monitors
• Implantable loop recorders
• Echocardiograms
• Pet scans
• MRI
• Cardiac CT
• Doppler fetal monitors
• Pacemakers
• Stents
• Catheters and accessories
• Guidewires
• Cannulae
• Electrosurgical procedures
• Valves
• Occlusion devices

That’s just those devices that can be categorized—as cardiovascular device makers great and small keep developing new technologies to fine-tune cardiac care, first-of-their kind technologies emerge exponentially. To build them, device makers may need a manufacturing partner with the expertise to innovate beside them.

In order to gain more perspective on the trends impacting the design and manufacturing of some of these devices, MPO spoke to the following experts from companies specializing in all corners of the cardio device manufacturing market over the past couple of weeks:

Matt Balko, president of business development at LightningCath, a Maple Grove, Minn.-based catheter component manufacturer.
Tom Berg, president of Mountain Manufacturing Technologies, a Lino Lakes, Minn.-based full-service manufacturing partner.
Kyle Degarady, senior product marketing Manager at Zeus, an Orangeburg, S.C.-based provider of medical polymer tubing and solutions.
Elizabeth Erdle, product Marketing Manager at Zeus.
Joelle Faught, director of quality at Plastic Design Company, a Scottsdale, Ariz.-based provider of precision micro molding, microfluidics, and microplates for the life sciences and medical device industries.
Shane Healy, senior director of product growth and strategy at Nordson Medical, a Salem, N.H.-based provider of extrusions, heat shrink, film cast, and balloon components and assembly.
Don Heaney, CEO of Advanced Powder Products, a Philipsburg, Pa.-based metal injection molding and metal 3D printing company.
Dr. Bob Hergenrother, vice president of research, development, and Innovation at Biocoat, a Horsham, Pa.-based developer of hydrophilic coatings used in medical devices.
Helin Räägel, Ph.D., senior biocompatibility expert at Nelson Labs, a Salt Lake City, Utah-based provider of microbiological and analytical lab testing.
Brian Stern, director of sales and marketing at Excel Medical Products, a Wixom, Mich.-based medical device OEM and contract manufacturer.
Pablo Vallejo, director and founder of Grupo Vallejo, a San Jose, Costa Rica-based professional services provider.

Sam Brusco: What more recent design and manufacturing trends are you noticing for your cardiovascular tech OEM customers?

Matt Balko: The minimally invasive medical device market is always evolving and exploring innovative new concepts and technologies. A few trends we’ve observed have been:

• Multifunctional catheters: Customers have been increasingly interested in developing catheters that can perform multiple functions within a single device. Embedded electronics, sensors, and specialized features are becoming more commonplace.
• Miniaturization in microcatheters: A growing demand for smaller and more intricate catheters requires robust upfront design, precision components, and skilled labor to produce high performance devices.
• Enhanced materials: Advances in material science have led to the development of novel materials with various advantages over more “traditional” materials. Understanding how to efficiently integrate these new materials into components and/or catheter assemblies has become increasingly important.

Tom Berg: We are seeing a significant increase in requests for highly precise, collapsible tools that heat set very complex 3D shapes in structural heart implantable applications. The tooling is used to heat set Nitinol into proprietary designed shapes of next-generation implants, while allowing for more efficient manufacturing at the OEMs as the new product scales into volume production.

CMOs have a broader engineering perspective, which allows us to apply the technologies used in one market segment, like structural heart, into a new custom application in another segment, like neurovascular. Also, we have found that OEMs are experts in design and clinical usage but very few OEMs are experts in high-precision metals manufacturing.

Kyle Degarady: The medical market is seeing a rise in minimally invasive surgeries. These applications in the cardiovascular market often rely on catheters to traverse complex and tortuous anatomies to gain access to the treatment site and deliver therapy. We see a trend where steerable catheters are becoming quite popular due to higher distal tip control, elevated accessibility to complex anatomical parts, improved catheter stability, and reduced radiation exposure. This trend is expected to fuel growth for steerable catheters in the cardio space, as well as in structural heart, vascular, orthopedic, uterine, neuro, and gastrointestinal surgeries.

Elizabeth Erdle: We’re seeing interest in lower durometer jacketing materials, along with interest in switching to easier-to-use fusing sleeves. These lower durometer jacketing materials are lubricous, flexible, and atraumatic, but do present a challenge from the manufacturing side of things, especially as the catheter gets smaller. After reflowing the shaft, the final manufacturing step of removing the FEP fusing sleeve can be very delicate. It’s not uncommon, even with experienced operators, for the skiving tool’s razor to accidentally damage the underlying catheter shaft, rendering it useless. To combat these nicks that have plagued manufacturing lines for decades, peelable heat-shrink is a solution many are opting to switch to due to the cost savings, even in legacy catheter lines.

Joelle Faught: The advent of percutaneous interventional technology is now becoming the primary standard of care for medical treatments. Benefits include reduced hospital stays, reduced anesthesia, reduced risk of sepsis, reduced scarring, and equivalent or better outcomes. Increased use of percutaneous interventional procedures heightens the demand for smaller cardio devices that fit within patients’ arteries and veins. The designs of cardio devices now require thinner wall sections, smaller outer diameters, and tighter tolerances—some within one-tenth of a thousandth of an inch!

We also see increased requests for branded products and signature colors for cardio devices. This requires validation of customized colorant blends,. which are also validated for medical-grade plastics and consistent quality control for the manufactured product.

Shane Healey: We are seeing customers working to eliminate expensive manufacturing steps from their device manufacturing operations through optimized material performance. For example, applying hydrophilic coating can be costly, so customers are challenging their design requirements and the need for the friction coatings provide. There is definitely a focus on performance vs. cost—we have seen customers work to qualify extruded tubing produced with lubricious additives to eliminate the need for downstream coating applications. Customers are really focusing on yields in their manufacturing processes and are turning to component producers to assist in their efforts. For example, in the heat shrink space we have seen interest in production, with a high degree of transparency to allow an operations team a better view of the assembly before activating the heat shrink and reflowing the product. If the customer can improve positioning of jackets to be reflowed using the heat shrink, this can lead to yield improvements. 

Don Heaney: With the increase in use of robotics in emergency cardiac situations—like the ECMO and Impella devices—there is a need for continued improvement and innovation in this market. We are committed to providing assistance in early design concepts through final product development for these types of products.

Dr. Bob Hergenrother: One of the largest trends we are seeing is using smaller, softer, and thinner substrate materials. Using these materials means our customers must ensure the materials can be coated to match lubricity, durability, and particulate performance criteria they have seen on prior projects.

Dr. Helin Räägel: We assist in defining an appropriate test article, which is especially useful when dealing with a product family with numerous devices, or when a device to be tested is very complex (e.g., different components with different contact types and/or duration, liquid products, in-situ curing devices, etc.). Getting additional input from a laboratory that understands the testing, as well as the potential roadblocks, can be very helpful. In addition to that, having a team of experts available to discuss through any unexpected results or figuring out the next steps can be a powerful partner to have.

Brian Stern: With the development of new techniques and procedures in cardiovascular medicine, there has been a significant increase in demand for larger bore hemostasis valves. These valves control bleeding while accommodating larger catheters and interventional devices needed for interventional procedures that require larger vascular access, such as TAVR and EVAR. In the past few years, there has also been an initiative for the compliance of hemostasis valve connections with the ISO 80369-7 standard. The standard dictates the requirements for small bore luer connections used in intravascular applications, and it is intended to prevent misconnections that could potentially cause harm to patients. Many OEMs have had to make design modifications and perform testing to demonstrate dimensional and functional compliance prior to the suggested compliance date set by the FDA for the end of 2023.

Pablo Vallejo: We pretty much see monitors and devices for self-control and medical applications in chronic illnesses like diabetes, hypertension, cancer, and HIV. All of this is because based on our market studies and reports, we have noticed a trend to keep people away more from hospitals and be admitted only when it’s totally needed—otherwise, patients want to take care by themselves at home, work, or while traveling. Most of these devices also link to a software app, where all the data is tracked by doctors in real time and a record is kept in a web file. Customers are asking us more to do not only engineering for the devices, but also design, software, and manufacturing, all in one vendor. Another trend we notice is there are many companies and individual parties innovating—setting patents but not necessarily having a physical facility to manufacture. 

References

1. bit.ly/mpo1123cardio