Structural heart interventions are one of the many exciting frontiers in cardiovascular medicine, providing minimally invasive techniques for conditions that once required open-heart surgery. Devices such as structural heart occluders and interatrial shunts have become essential tools for cardiologists, offering effective, life-changing solutions for patients with congenital or acquired heart defects. As a result of the rising prevalence of heart conditions, GlobalData predicts that the structural heart occlusion devices will be worth $8.55bn by 2034, growing at a compound annual growth rate (CAGR) of 7.4%.
This progress is built on clever design and advanced materials engineering, with delicate yet durable implants. However, for these devices to perform reliably within the heart, every component must meet exact standards. This is where companies such as Alleima play a vital role, delivering design, engineering, and the high-performance materials that are enabling a new generation of cardiac devices.
Precision at the heart of innovation
Structural heart interventions treat conditions such as atrial septal defects (ASDs), patent foramen ovale (PFO), or heart failure with precision-engineered implants delivered through catheter-based procedures. This shift from open-heart surgery means faster recovery, reduced complications, and broader accessibility for high-risk or elderly patients.
Structural heart occluders are designed to seal abnormal openings in the septum between the heart’s chambers, which can lead to complications such as strokes, migraines, or paradoxical embolism if left untreated. These devices – often based on nitinol mesh or discs – must be extremely reliable and flexible, capable of being delivered through slender catheters yet expanding into a stable form that integrates with the cardiac tissue. Nitinol guidewires play a vital role in delivering these occluders during transcatheter, minimally invasive procedures, ensuring precision and ease of placement within the complex anatomy of the heart.
Alleima contributes to this success with its material expertise, engineering services and precision manufacturing capabilities for complex components and solutions. Its longstanding experience in processing nitinol, a, flexible, biocompatible, shape-memory alloy, allows components to endure the biomechanical stresses of the heart, combining flexibility with strength and corrosion resistance. These properties are essential for implants that must withstand constant movement, exposure to blood flow, and the body’s immune response, all while functioning discreetly and reliably.
Regulating cardiac pressure with interatrial shunts
While occluders focus on closure, interatrial shunts are about control. These devices often consist of self-expanding nitinol frames, sometimes encapsulated with an expanded PTFE to limit tissue overgrowth. The objective is to create a small, controlled passage between the left and right atria, relieving elevated left atrial pressure in heart failure patients. In conditions such as heart failure with preserved ejection fraction ( HFPEF), where traditional drug therapies often fall short, interatrial shunting offers a promising mechanical alternative to alleviate symptoms and improve quality of life. Such devices demand materials that maintain structural performance amid dynamic pressure gradients and pulsatile flow, all while avoiding thrombosis or tissue overgrowth.
As cardiac therapies become increasingly sophisticated, the performance expectations placed on implantable materials will only intensify. Next-generation devices may demand ultra-thin profiles, shape-memory and sensing characteristics, bioresorbable materials, or surface technologies that enhance endothelialisation and minimise complications.
Alleima supports medical device manufacturers in addressing these challenges through its expertise in designing, developing and processing complex nitinol components and solutions, which are customised to withstand the most demanding physiological environments. By investing in cutting-edge R&D to develop smarter, lighter, and more adaptable medical solutions tailored to the evolving needs of cardiac device designers, Alleima is well positioned for the future of medical technology. Through progressive partnerships with innovators in the field as well as leading medical device manufacturers OEMs, Alleima continues to advance the industry by delivering solutions for life-changing medical devices.
