For decades, surgical aortic valve replacement has been constrained by an uncomfortable balance. In young and middle-aged patients, mechanical valves provide durability at the cost of lifelong anticoagulation, whereas biological prostheses avoid this burden but pay the price of structural valve degeneration. At its core, a fully satisfactory solution has remained elusive.

Within this context emerges the TRIFLO prosthesis, developed by Novostia, with a clear ambition: to challenge this long-standing dilemma through a trileaflet surgical valve manufactured entirely from a flexible polymer.

TRIFLO is a surgical aortic valve prosthesis with a trileaflet design, conceived to closely replicate the biomechanics of the native valve. Unlike biological valves, it does not rely on animal tissue but instead uses a highly flexible synthetic polymer engineered to withstand millions of cycles while minimizing fatigue and calcification.

Current clinical evidence comes from the PILATUS study, a first-in-human, prospective, open-label, non-comparative trial registered at ClinicalTrials.gov (NCT06119607). The study enrolled 10 patients with an indication for surgical aortic valve replacement, with the primary objective of assessing device safety and early functional performance.

To date, available data remain preliminary and derive from registries and official communications: implantations were technically successful, and early clinical outcomes have been described as favorable. Beyond this, the information released so far is still very limited, with no detailed results published in peer-reviewed scientific journals.

According to the developers, the TRIFLO valve can be safely implanted using conventional surgery and demonstrates satisfactory early function. The core objective of the clinical development program is to prove that the polymeric material can combine long-term durability with the absence of chronic anticoagulation, a goal that no valve prosthesis has consistently achieved to date.

COMMENTARY:

The main message of the PILATUS study is the initial clinical feasibility of the prosthesis. TRIFLO can be implanted without relevant technical difficulties and shows appropriate early performance. For now, this is the only legitimate conclusion. Everything else should be interpreted strictly as proof of concept.

The true relevance of TRIFLO does not lie in its early outcomes, but in what it would represent if its promise were fulfilled. Should this polymer demonstrate durability comparable to that of a mechanical valve without the need for anticoagulation, the impact would be substantial.

From a materials perspective, the rationale is straightforward. Calcification of biological prostheses is closely linked to the presence of animal tissue, cellular remnants, and inflammatory mechanisms. A chemically stable and inert synthetic polymer lacks this biological substrate, theoretically leading to a marked reduction in the risk of structural calcification. In addition, its flexibility is intended to minimize repetitive mechanical stress, one of the classic limitations affecting valve durability.

If this hypothesis were confirmed, it would represent a genuine paradigm shift. The historical mechanical versus biological dilemma would fade away, along with many of the complex decisions currently faced when treating young or intermediate-risk patients.

A potential domino effect: what about TAVI?

The impact would not be confined to surgery alone. A durable surgical valve that does not require anticoagulation could relatively diminish the role of TAVI, at least in non-elderly patients with low or intermediate surgical risk. The expansion of TAVI has partly relied on the limitations of traditional surgical prostheses. If those limitations were removed, the balance could tilt back toward surgery in selected patient profiles.

This would not represent a return to the past, but rather a redefinition of indications, with surgery regaining prominence in patient groups where the debate is currently wide open.

Nevertheless, this entire scenario remains largely theoretical. Available evidence is derived from a very small number of patients, without a comparator group and with extremely short follow-up, precluding any solid conclusions beyond initial feasibility and implant safety. This is compounded by the absence of detailed published data on key parameters such as transvalvular gradients, valve thrombosis, embolic events, or structural durability, all of which will be decisive in determining the true clinical impact of this prosthesis. Biocompatibility and the thrombotic profile of the polymer under real-world conditions will be as critical as long-term structural performance. It should also be remembered that the history of valve surgery is filled with devices that appeared promising in concept but ultimately failed the test of time.

TRIFLO represents one of the most ambitious proposals in valve surgery in recent years. If it delivers on its promise, it could redefine aortic valve replacement for decades. For now, however, it should be approached with caution: a brilliant idea at an embryonic stage, whose true value will only be revealed through long-term follow-up. Precisely because of its highly innovative nature and the profound paradigm shift it could entail if its results are confirmed, we believe that, despite being a very early experience, this prosthesis deserves to be discussed and analyzed in our blog.

As so often in innovation, the key question is not whether it works today, but whether it will withstand the wear and tear of time.

REFERENCE: