Surgeons often face a fundamental challenge when using catheters—a lack of real-time sensory feedback as the device navigates sensitive tissues inside the body. Modern catheters are essentially passive tools, thin tubes or wires with no feedback beyond external imaging technologies.

Responding to this need, researchers at Indiana University Bloomington created microscopically thin fibers capable of sensing hydrostatic pressure in the veins.¹ The technology aims to transform how surgeons navigate minimally invasive procedures that use endoscopes and catheters, for example inserting stents to restore blood flow to the heart.

Hydrostatic pressure is a sense unavailable to humans—but common in fish—and can help identify the site of a vein blockage to help properly place interventional devices. 

“The fiber offers a sixth sense inside the vein,” said Dr. Alexander Gumennik, FAMES Lab director and an associate professor of intelligent systems engineering at the IU Luddy School in Bloomington. “It can predict and prevent tissue damage critical to patient safety and assist the surgeon in the insertion of the medical device.”

The sensors were developed by the IU FAMES Lab—Fibers and Additive Manufacturing Enabled Systems, part of the IU Luddy School of Informatics, Computing and Engineering. They were developed under a “master research agreement” established in 2021 with Bloomington-based manufacturer Cook Medical. Dr. Gumennik said Cook saw the fiber sensors as a match for the company’s catheters and endoscopes because they’re both long and thin, flexible, and biocompatible.

“In meeting with Dr. Gumennik and his team, we recognized the versatility of the technology platform for clinical needs,” said Sean Chambers, director of R&D at Cook Medical. “We also saw great potential in the skillset of his students and the training they were getting from his mentorship. The expertise and innovative approach the FAMES Lab provided to this collaborative research project have been instrumental in advancing our understanding of the potential of fiber-based sensors in medicine.”

The “smart catheter” tech has only been tested in simulated clinical environments. Dr. Gummenik said the project seeks a specific Cook Medical product to test its viability. This is the first step toward animal, then human clinical trials of the fiber sensors.

Merve Gokce, an IU Ph.D. student in Gummenik’s lab who was project manager and researcher on the lab’s partnership with Cook, is also working on embedding smart fibers into bioprinted material to build artificial vascularization. It’s named the “cyborg flesh” project that could create a biomaterial that can deliver nutrients and oxygen the same way as natural tissue. The work hopes to build a “cardiac patch” that could repair or replace damaged heart tissue.

Developments like these aim to transform cardiovascular surgical procedures. The cardiovascular device market is ripe for innovation, considering the rising threat of cardiovascular disease and unmet clinical needs in cardiac surgery. This article will explore some of the latest developments by medtech firms in this area, as well as how manufacturing partners are meeting the demands placed on cardiovascular device makers by this dynamic market.

Abbott Laboratories

The company’s Navitor transcatheter aortic valve implantation (TAVI) system received U.S. Food and Drug Administration (FDA) approval in 2023 for patients with severe aortic stenosis at high or extreme risk for open-heart surgery. According to Abbott, it is the only self-expanding TAVI system with leaflets in the native valve. Its NaviSeal fabric cuff is designed to reduce paravalvular leak (PVL)—backflow of blood around the valve frame.

In August of this year, Navitor earned a CE mark to expand its indication to treat patients with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery. The expanded CE mark was based on the VANTAGE study, which showed a 2.3% of all-cause mortality or fatal stroke/stroke with disability at 12 months. No patients exhibited moderate or greater PVL at 30 days and 13.6% showed mild PVL, which is considered a low rate.

Navitor also had a 97% rate of technical success with no procedural deaths and sustained, excellent hemodynamic performance at 12 months.

“This expansion significantly benefits patients, who can now receive the minimally invasive procedure even if they are at low or intermediate risk from open-heart surgery,” said Dr. Lars Sondergaard, chief medical officer and divisional VP of Medical Affairs for Abbott’s structural heart business. “This translates to faster recovery times, reduced procedural risks, and an improved quality of life, while also preserving options for future cardiac interventions if future management is necessary.”

At August’s ESC Congress, ESC and the European Association for Cardio-Thoracic Surgery (EACTS) unveiled new guidelines to manage valvular heart disease. The organizations revealed updated transcatheter edge-to-edge repair (TEER) guidelines. Abbott said the updated guidelines for TEER therapy also represent a significant positive shift for both patients and physicians, particularly in treating mitral and tricuspid regurgitation.

“More patients with severe secondary MR who previously might not have been considered or referred for TEER will now likely be offered this recommended treatment,” said Dr. Sondergaard. “Also, the recommendation for tricuspid TEER will lead to more discussions and evaluations for this therapy.”

Mitral valve TEER was upgraded from a treatment that “should be considered” (IIa) to a “recommended treatment” (Class Ia) for select patients with severe functional (or secondary) mitral regurgitation (MR). Tricuspid valve TEER was also upgraded from a treatment that “may be considered” (IIb) to one that “should be considered” (Class IIa) for select patients with severe functional tricuspid regurgitation (TR).

“For physicians, the updated classifications provide stronger, evidence-based guidance for when they should consider and recommend TEER,” said Dr. Sondergaard. “This simplifies complex treatment decisions and reduces ambiguity.”

The new guidelines offer further support for using the company’s MitraClip and TriClip for MR and TR, backed by evidence from multiple clinical studies, including COAPT, TRILUMINATE, TRILUMINATE Pivotal, bRIGHT, RESHAPE-HF2 and TRI.fr, that demonstrate the therapies’ effectiveness.

“In essence, these guideline updates reflect the maturation of TEER technologies and the accumulation of compelling clinical evidence,” said Dr. Sondergaard. “They will undoubtedly lead to more patients receiving timely and effective treatment for these challenging valvular heart diseases, ultimately improving their health outcomes and quality of life.”

In May, the company received FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR) system to treat mitral valve disease. Tendyne resolves unmet clinical needs in patients with severe mitral valve calcification (MAC), a buildup of calcium in the annulus that supports the mitral valve.

“Some patients with MAC can be very difficult to operate on and many are considered too high risk for open-heart surgery due to multiple co-morbidities or other factors,” said Dr. Sondergaard. “At the same time, these patients can’t always be successfully treated with existing transcatheter therapies like Abbott’s MitraClip. For these patients, Tendyne offers an alternative minimally invasive way to replace the valve that’s impacted by mitral regurgitation or narrowed stenosis.”

Edwards Lifesciences

The company’s Sapien M3 mitral valve replacement system received EU approval in April of this year to treat patients with symptomatic mitral regurgitation deemed unsuitable for surgery or transcatheter edge-to-edge therapy. According to Edwards, it’s the first approved transcatheter valve replacement therapy using a transfemoral approach to treat mitral regurgitation.

“We were the first to gain CE mark for a transcatheter tricuspid valve replacement system, and with the Sapien M3 system’s approval, Edwards is now the only company providing a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves, meeting the broad and diverse needs of these patients in Europe,” Edwards corporate VP, transcatheter mitral and tricuspid therapies, said in a press release.

The procedure to implant Sapien M3 involves two steps, delivering the dock and then the valve to completely replace the mitral valve. The dock wraps around the native mitral leaflets to pull them and the chordae inward toward the center of the dock, bringing the papillary muscles closer together. The dock creates a stable, consistent landing zone to place the valve.

The company’s Evoque transcatheter tricuspid valve replacement (TTVR) system earned a CE mark in 2023, FDA approval in 2024, and Health Canada approval in June of this year. The TTVR system is used to treat tricuspid regurgitation, indicated to improve health status in patients with symptomatic severe TR despite optimal medical therapy.

“Patients suffering from severe tricuspid regurgitation endure debilitating symptoms and poor quality of life and are desperate for effective treatment. The EVOQUE system is able to fully replace the tricuspid valve, eliminating tricuspid regurgitation in a wide range of anatomies,” said Dr. Neil Fam, interventional cardiologist and director of the Structural Heart Program at St. Michael’s Hospital, Toronto. “The significant improvements in patients’ quality of life are remarkable, with Evoque now offering a therapy to many patients who previously had no treatment options.”

Evoque features a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the company’s bovine pericardial tissue. The valve comes in three sizes and was proven superior compared to medical therapy alone for the one-year primary endpoint in its TRISCEND II randomized controlled pivotal trial.

Edwards said there is a significant unmet patient need in the area of structural heart failure with millions of patients and an unbearable quality of life. So, the company is looking at multiple modalities to help these patients, including advancing heart failure care with the Cordella sensor, which the company acquired from Endotronix last year. 

The Cordella implantable pulmonary artery (PA) sensor received FDA approval in 2024. It delivers daily PA pressure and other vital data with an implanted sensor and noninvasive health tools. The sensor enables seated PA pressure measurements with a handheld reader. Secure messaging can be done on a tablet between the clinical team, patient, and caregiver.

Edwards also highlighted valvular disease undertreatment as an area of unmet patient need in heart valve surgery that requires further innovation. While not R&D-specific, the under-diagnosed and under-treated rates of heart valve disease are significant, and these patients also suffer with life-altering symptoms. As such, the company said it’s also innovating in the area of patient awareness about the symptoms of and treatment options for valvular heart diseases.

BD (Becton, Dickinson and Company)

Hemodynamic monitoring during surgery tracks blood pressure, heart rate, and cardiac output to ensure stable circulation. Standard methods include non-invasive blood pressure cuffs and ECG, as well as more invasive arterial catheters and central venous catheters for unstable patients or major surgeries to measure blood pressure and CVP—a measurement of the pressure in the large veins that return blood to the heart’s right atrium. 

Poor hemodynamic control can lead to acute kidney failure or stroke. As such, medtech companies like BD are working to advance hemodynamic monitoring to bring about more successful cardiovascular procedures.

BD said the 1980s need to be revisited to understand today’s innovations in hemodynamic monitoring, when the Anesthesia Patient Safety Foundation and American Society of Anesthesiologists introduced minimal monitoring standards. These standards anticipated future technologies that would improve patient safety.

“Advanced hemodynamic monitoring required accuracy, reliability, and ease of use,” said Ricky Bengel, director of global medical affairs at BD. “BD met these needs and went further by integrating predictive algorithms powered by machine learning. The Hypotension Prediction Index (HPI) is a key innovation. It detects early signs of instability before blood pressure drops dangerously low, helping clinicians intervene proactively.”

In April of this year, BD released HemoSphere Alta, an advanced hemodynamic monitoring platform with predictive AI-based algorithms to help proactively address blood pressure instability and optimize blood flow. HemoSphere Alta also introduced Cerebral Autoregulation Index (CAI) available with a ForeSight IQ noninvasive sensor placed on the patient’s forehead, combined with an Acumen IQ sensor connected to the arterial line. The advanced near-infrared spectroscopy (NIRS) technology monitors cerebral oxygenation.

According to BD, CAI personalizes blood pressure targets by monitoring brain perfusion, moving from generic thresholds to tailor care to each patient’s physiology. HemoSphere Alta marries the three algorithms: HPI, Global Hypoperfusion Index (GHI), and CAI on one screen to provide a comprehensive view of both left and right heart function.

“HPI predicts when compensatory mechanisms are failing and hypotension is imminent. GHI, derived from the Swan-Ganz IQ catheter, predicts a drop in mixed venous oxygen saturation (SvO₂), a key indicator of the global balance between oxygen delivery and consumption,” said Bengel. “CAI adds cerebral insights, helping clinicians understand when brain perfusion is at risk. HemoSphere Alta shifts monitoring from reactive to predictive, enabling earlier, more targeted interventions and individualized care.”

The Swan-Ganz IQ catheter is the next generation of pulmonary artery catheter technology. It applies a smart algorithm to analyze the right ventricular pressure waveform and provide continuous cardiac output that updates every 10 seconds.

“Swan-Ganz IQ, BD’s advanced pulmonary artery catheter, provides continuous, real-time insights into right heart function and tissue perfusion,” said Bengel. “It integrates seamlessly with HemoSphere Alta, offering real-time insights. It provides traditional metrics like right atrial pressure (RAP) and pulmonary artery pressures (PAP). What is new with the Swan-Ganz IQ is continuous right ventricular pressure (RVP) monitoring, plus truly continuous right ventricular cardiac output (RVCO) every 10 seconds, which is critical for capturing dynamic changes in right ventricular performance.”

Using it, clinicians can directly measure right ventricular pressures and use GHI to evaluate oxygen delivery and consumption. This can help identify issues like anemia that may impact the patient. HemoSphere Alta consolidates all data into one interface to simplify workflows and guide treatment decisions.

Cardiotech Collabs

Technological advancements and clamor for minimally invasive procedures are powering innovation in the cardiovascular device market. Cardiotech OEMs are investing heavily in research and development to create next-generation devices like transcatheter heart valves, bioresorbable stents, smart pacing devices, and many others.

To stay competitive in an evolving market landscape, these OEMs often collaborate with manufacturing partners to keep the pace of innovation strong. As such, these manufacturing partners also hold a steady finger on the cardiotech market’s pulse.

In order to gain insights on trends impacting cardiotech manufacturing, Medical Product Outsourcing spoke to the following industry experts over the last few weeks:

• Jochen Becker, (former) senior VP global sales & marketing, Vascular Systems, B. Braun
• John Cooney, VP of R&D, Cardio & Vascular, Integer Holdings Corporation
• Doug Hutchison, chief commercial officer, Confluent Medical
• Scott Huter, CEO, REV1 Engineering
• John Lipari, chief commercial officer, PrecisionX
• Jose Maeso, chief technology officer, Lighteum Medical
• Bob MacKinnon, director of manufacturing, REV1 Engineering
• Matyou Shahbaz, general manager, Cirtec Medical

Brusco: What clinical, technological, or operational trends are most heavily impacting your cardiovascular device manufacturing business?

Jochen Becker: With SeQuent Please (NEO) we developed and marketed the first clinically proven drug-coated balloon (DCB) and started a new era of interventional treatment options. In its beginning, the technology was only used by a handful cardiologists, who believed in the concept of “really leaving nothing behind,” trying to avoid several layers of stents in in-stent-restenosis (ISR) or metal at all in small vessel disease (SVD) treatment. It took nearly two decades to convince the majority of interventionalists that reducing the number of stents being used might offer similar clinical outcomes while reducing the complexity of procedures. We could also reduce the duration of DAPT compared to stenting, a huge benefit for patients with high bleeding risks. 

Due to our close collaboration with clinicians, over 100 clinical studies on SeQuent DCBs have been published. Thanks to vast clinical evidence, this technology has evolved into a fully accepted treatment option in the Asia Pacific and Middle East markets, is becoming increasingly important in Europe, and is starting its journey in North America.

We see a great opportunity to combine the DCB concept with bio-resorbable scaffolds (BRS). Since this technology has almost come to an end due to negative clinical results from a previous product, for some time many cardiologists did not expect this product concept would come back. With newer technologies and emerging clinical data, we strongly believe in the future of those products. We offer the Fantom Encore BRS, which has presented promising five-year follow-up data in the FANTOM II trial. The product opens a new opportunity to combine DCB treatment with a true “leave nothing behind” option if a scaffold is still needed for bail-out stenting. Further studies are needed to continuously develop this therapeutic concept and positively influence existing guidelines of cardiac societies.

John Cooney: Speed to market remains one of the most critical requirements for OEM customers, especially during the early concept select phase. At this stage, customers need to quickly iterate through multiple concepts before finalizing the design. We have developed a rapid prototyping program that allows customers to receive prototype samples in as little as two weeks, significantly reducing their overall development cycle. These rapid prototyping centers are strategically located in key medical hubs such as Minnesota, Galway, and other locations.

After the concept select phase, we leverage our Design for Manufacturability (DFM) and process development to ensure customers receive high-quality products manufactured at optimal costs. Additionally, our vertically integrated supply chain and skilled development and operations teams enable us to respond rapidly to evolving customer and market requirements.

Doug Hutchison: Several key trends are actively shaping the trajectory of our cardiovascular device manufacturing. There is a growing demand for high-cycle fatigue-resistant nitinol components, especially as devices become smaller. In addition to improved nitinol performance, stronger polyimide tubing is needed without compromising the inner lumen of the catheter. We have been investing heavily in these two areas to meet customer demand for smaller devices without compromising strength and durability.

Scott Huter: From a technological and operational standpoint, the ongoing limitations of automation are having a significant impact. Despite the broader move toward Industry 4.0 and automation in manufacturing, cardiovascular devices—especially complex catheters—still rely heavily on fine manual labor. These are not plug-and-play components; they require skilled technicians for assembly and integration, often under microscopes. As a result, access to highly trained labor pools and the ability to scale quality efficiently have become central to our value proposition.

Large-scale manufacturing environments tend to be rigid and optimized for high-volume production. That model doesn’t work for companies that need to move quickly, adapt designs, and produce small batches for clinical validation. That’s why an infrastructure built for flexibility is increasingly critical in this evolving landscape.

John Lipari: As cardiovascular devices get smaller, housings and components must be manufactured to ever-tighter tolerances. At the same time, OEMs are pushing into harder, more advanced biocompatible materials, which require new levels of precision and control. We have invested heavily in engineering to stay ahead of these demands, engineering robust manufacturing processes that not only pass initial qualification but also scale reliably to handle aggressive long-term production volumes once programs are cleared.

Bob MacKinnon: One of the most influential clinical trends we see is the shift toward requiring substantial clinical evidence—and in some cases, even early commercial traction—before companies can attract acquisition interest or secure later-stage investment. This is driving demand for fast, flexible manufacturing support during early development stages, particularly for devices heading into first-in-human studies or pilot trials.

Jose Maeso: Miniaturization and the shift toward smarter, more complex devices are driving transformation in cardiovascular manufacturing. As feature sizes shrink and tolerances tighten to enable innovation in microcatheters delivering more efficacious therapies, the demand for precision machining and advanced materials has grown exponentially. Technologies like pulsed field ablation (PFA) are reshaping electrophysiology, requiring components that can transmit and receive signals with high fidelity—often through platinum alloys and intricate nitinol geometries.

Operationally, speed to market is paramount as cardiovascular technologies evolve rapidly. To meet this demand, we’ve invested in rapid prototyping capabilities, stocked a wide array of platinum group metal (PGM) and nitinol tubing, and built dedicated lab spaces for laser cutting and Swiss micromachining to support fast-turn development cycles. We also partner with customers on tuning their electropolishing process to optimize electrolyte chemistries and dwell times, often driven by nitinol end application use as implantable or high-cycle fatigue. Then over the past five years, we’ve experienced a significant surge in demand for nitinol materials, which led to the expansion of our tubing and sheet manufacturing operations to our newly built Mexicali Nitinol Center of Excellence, opened in 2022.

Matyou Shahbaz: We see a clear shift toward multifunctional, minimally invasive catheter-based therapies for faster, safer treatment outcomes. This involves a growing emphasis on device miniaturization, integrated sensing/electronics, and novel materials for access, delivery, and structural implants. Operationally, OEMs are prioritizing vertically integrated partners to strengthen supply chain resilience and accelerate time to market. We meet these needs with design-led execution, simulation-driven engineering, rapid prototyping, robust design controls, and DFM/DFA tightly linked to manufacturing and regulatory support across all stages of product development.

Reference

1. bit.ly/mpocardio1125