Revolutionary Nitinol-Based Cardiac Device Transforms Heart Treatment: Inside Cardiac Dimensions' Game-Changing Innovation

The Cardiac Dimensions Carillon Mitral Contour System represents a breakthrough in medical device technology, leveraging nitinol's exceptional superelasticity and shape memory properties to revolutionize cardiac care.

This innovation has created significant opportunities in medical device sales, particularly for professionals seeking medical device sales jobs in the cardiovascular sector.

The Carillon Mitral Contour System stands as a testament to modern medical device engineering, offering a minimally invasive treatment for mitral valve regurgitation. This sophisticated system, developed by one of the leading medical device companies in the cardiovascular space, demonstrates how advanced materials and catheter technology can transform patient care.

In a significant milestone for the company, Cardiac Dimensions has secured both European approval and reimbursement for the system. The company is currently advancing through a pivotal trial for U.S. approval, which could potentially expand medical device sales opportunities and impact medical device sales salary structures in the cardiovascular segment.

"We never would have been able to do what we can without nitinol. … The catheter technology coupled with the nitinol metal technology are the two things that really drive the device."
— Rick Wypych, Cardiac Dimensions President and CEO

In an exclusive interview with Medical Design & Outsourcing, Wypych provided detailed insights into the Carillon Mitral Contour System's functionality, development journey, and manufacturing processes.

How the Cardiac Dimensions Carillon Mitral Contour System treats mitral regurgitation

Revolutionary Technology

The innovative Carillon system represents a significant advancement in medical device technology, utilizing a catheter-delivered heart implant to address mitral regurgitation through a unique approach. Rather than directly interfacing with the valve leaflets, the implant employs nitinol's remarkable shape memory and superelastic properties to achieve its therapeutic effect.

Precision Delivery Process

The delivery process involves introducing the implant through the jugular vein using the advanced catheter system, which maintains the device in a compressed state. Upon reaching the coronary sinus, the implant expands with precision, performing a critical cinching action on the mitral valve annulus.

This mechanical adjustment ensures complete contact between the leaflets during valve closure, effectively restoring normal blood flow patterns.

The engineering excellence of the Carillon implant is evident in its sophisticated locking mechanism within the coronary sinus. The device maintains its position through carefully calibrated radial force, while simultaneously incorporating a retrieval feature that allows physicians to remove it if necessary.

The implant's design includes two anchors joined by a connecting bridge, with specialized lockbumps integrated into each anchor point. This attention to detail in design and functionality exemplifies why Cardiac Dimensions stands out among medical device companies in the cardiovascular sector.

The system's innovative approach to treating mitral regurgitation has garnered significant attention in the medical device industry, creating new opportunities for medical device sales professionals and potentially influencing medical device sales salary structures in the cardiovascular market segment.

"The anchors create the hoop shape, and at the end of one anchor there's an eyelet — a spinned wire where it creates a circle that's smaller than that bump — and we push the circle over the bump to keep it locked in place to have that radial force maintained within the vein. Then it holds when we pull to cinch the device, and we do it in a similar way on the proximal anchor. Once we get the tension in the location that we want, we can lock it with that in place and the device is held in place with radial force, as it will be for the rest of the life of the patient."

— Rick Wypych, explaining the device's locking mechanism

This innovative locking mechanism represents a significant advancement in medical device technology, creating new opportunities for medical device sales professionals specializing in cardiovascular solutions. The device's sophisticated engineering and reliable performance have positioned it as a valuable addition to the portfolios of leading medical device companies.

"If we don't like what we see because it's not as efficacious as we want or there's a safety issue in that we've created a perfusion problem in an artery, we simply recapture the device and reinstall a different device in a different location or a different size or under different tension to optimize it for the patient."

— Rick Wypych, on device safety and flexibility

Procedure Efficiency

The procedure takes 15 or 20 minutes and typically doesn't require a stay in the intensive care unit.

Comparative Advantage

Traditional TMVR clip implantation procedures typically require several hours in the catheterization laboratory and one to two days in the ICU.

Developing the Carillon implant

Company Origins

The genesis of Cardiac Dimensions in 2000 by Scout Medical Technologies marked a pivotal moment in medical device innovation. The company emerged from a strategic initiative by the incubator to identify surgical procedures with substantial market potential that could be transformed through minimally invasive solutions.

When Wypych joined the company in 2003, the focus on mitral regurgitation was already established, reflecting the company's commitment to addressing significant unmet medical needs.

"We had some ideas on a whiteboard and a lot of R&D thought behind a million different ideas... That's where the Carillon device popped out: make it very minimally invasive, make it very small so it fits in a 10 Fr catheter, make it recapturable so if we don't see the efficacy or the safety we like, we can recapture the device and it's no harm, no foul to the patient, and make it extremely easy to use so you don't have the top 1% of users able to successfully use it, you have 99% of the users successfully using it."
— Rick Wypych

Design Challenges

The development process faced numerous technical challenges, particularly in designing an effective anchoring mechanism for the coronary sinus while maintaining recapturability - a feature not possible with conventional stents or tethers.

User-Centric Approach

The engineering team's focus on creating a device that could be easily used by a broad range of physicians, rather than just elite specialists, has proven to be a strategic advantage in the competitive medical device market.

"We looked at oversizing the device for the vein [and] found the veins are very compliant, and therefore we could use a pretty significant amount of radial force to hold it in place and not have to use sutures or barbs or anything more invasive or more creative to get the device to hold in place while we cinch tension."
— Rick Wypych

This innovative approach to vein compliance has revolutionized how medical device companies approach anchoring mechanisms. The engineering team's deep understanding of vascular physiology enabled them to develop a solution that maximizes device stability while minimizing tissue trauma.

Advanced Catheter Design

That method of anchoring and cinching — and retrieval, if needed — demanded a sophisticated delivery catheter system that could not only navigate effectively to the target site but also maintain structural integrity under the substantial compression forces required for both anchor locking and device recapture.

"The end of the catheter opens up large enough to recapture the device and gobble it back up to get it back in the system without perforating the vein or anything else."
— Rick Wypych

Strategic Manufacturing Decisions

While Cardiac Dimensions strategically outsourced the manufacturing of the delivery catheter to leverage specialized expertise, the company made the critical decision to maintain in-house production of the implants. This strategic choice required building substantial internal nitinol expertise through extensive "trial-and-error" processes and close collaboration with metallurgists and nitinol suppliers.

"We needed to see, for example, how much in the way of carbon inclusions in the wire could be allowed without degrading the strength of the wire, [what] the best way was to shape the wire and how much can you bend it in one set versus two sets or three sets?"
— Rick Wypych

Team Excellence

"We've had a pretty stable team within R&D and manufacturing where they're at 10, 15, 20 years with us. So, we have a lot of in-house, nitinol experience, and they know the device better than anybody in the world."
— Rick Wypych

Material Engineering Breakthrough

A critical engineering challenge emerged in the selection of materials for the crimp tubes that secure the nitinol wire anchors to the nitinol wire bridge. Initial attempts utilizing stainless steel for these tubes encountered significant wear issues.

"Part of it might have been the way that we were crimping and putting the wires in, and part of it might have been the different types of metal. Stainless is very rigid and hard, and nitinol tends to be a little bit softer."
— Rick Wypych

The engineering team's systematic approach to problem-solving led them to evaluate the wear patterns and consider various alternative materials. The elegant solution emerged in the form of titanium crimp tubes, leveraging one of the constituent metals used in nitinol itself.

"Titanium was a complimentary metal and strong enough to hold the device together and crimp but didn't cause us other problems along the way... It solved the wear problems and everything else. It was a good solution all around."
— Rick Wypych

Pioneering Innovation: The Revolutionary Manufacturing Process Behind Next-Generation Cardiac Implants

Much of the in-house manufacturing of the Cardiac Dimensions nitinol implant is manual, requiring exceptional precision and expertise that positions the company as a leader among medical device companies. Wypych's characterization of the process as both art and science underscores the unique blend of technical knowledge and craftsmanship required in advanced medical device development.

"The science is the actual metal. The art is forming it."
— Rick Wypych

Precision Shape-Setting

This sophisticated manufacturing process involves a meticulously controlled sequence of operations. Cardiac Dimensions' proprietary shape-setting process begins with carefully bending the nitinol wire over specialized tooling before immersion in a precisely maintained 500°C molten salt bath.

The timing of this critical step varies "a few minutes … depending on the length of the wire and the bend in the wire and things like that," requiring experienced technicians who understand the nuanced behavior of nitinol under different conditions.

Surface Treatment

The subsequent surface treatment process, involving an acid-dipping procedure, represents another crucial step in ensuring device longevity. This treatment effectively eliminates microscopic imperfections and enhances the material's durability.

Strategic Growth and Market Expansion

The company's recent $53 million funding round marks a significant milestone in Cardiac Dimensions' journey, with Wypych confidently stating this should be their final funding requirement. The strategic timeline includes completing enrollment for the pivotal Empower trial by late 2026 or early 2027, followed by a targeted FDA premarket approval (PMA) submission around the close of 2027. While maintaining focus on the Empower trial as their primary objective, the company is simultaneously pursuing commercial growth opportunities in the European market, where they have already secured reimbursement coverage. This dual-track strategy has created expanding opportunities for medical device sales professionals who can navigate both clinical and commercial landscapes. The company's future trajectory is supported by a strategic partnership with an unnamed but significant player in the interventional medical device space, described as a "multibillion-dollar market cap, well-known, interventional-based type of company." This relationship, combined with proven commercial success in Europe, positions Cardiac Dimensions for multiple strategic options, including potential public offering or independent growth following U.S. market approval. Wypych articulates a clear leadership philosophy focused on creating value and maintaining optionality: "My goal and my job is to provide options for our investors," he explained. "We don't fund or run the company toward an IPO or a possible sale of the company or other acquisitions within the space that are complementary or use nitinol, for example, as a device or a method to solve for a problem. My job is to make sure that we do everything right as a company, maximizing Carillon and getting Carillon as established as possible. … The focus is to do what's right for the company and the device and the patient, and the doors will open from there." This strategic approach has positioned Cardiac Dimensions as an emerging leader in the medical device industry, creating opportunities for growth while maintaining unwavering commitment to product quality and patient outcomes.

The groundbreaking Carillon Mitral Contour System device combines advanced nitinol wire with premium titanium construction. [image courtesy of Cardiac Dimensions]