JenaValve Brand Guidelines: A Jena University Idea, Irvine & the Trilogy Valve

A university concept and a long road.

JenaValve takes its name from Jena, the university city in the German state of Thuringia. The company says its original design concept was developed by two professors of medicine at the city’s Friedrich Schiller University, Hans Figulla and Markus Ferrari, and it describes the path from that concept to an approved product as a road of more than 30 years. Its published timeline starts in 1995, with a patent for a percutaneous self-expanding aortic stent, and continues with a first stent design and first in-vitro implants in 1999, a patent in 2003 for an aortic valve replacement with early “locator” technology, the initial design of a transapical catheter in 2004 and a first animal study in 2005.

The company itself, the timeline says, was officially established in 2006 to develop a transcatheter valve for aortic regurgitation, or AR, a condition in which the aortic valve does not close properly and blood leaks backward into the heart, as MedTech Dive has described it. The approach, transcatheter aortic valve replacement or TAVR, delivers a new valve through a catheter rather than through open-heart surgery, the company explains.

Europe came first. JenaValve says it received a CE mark in 2011 for aortic stenosis with its Porcine Root valve, implanted transapically, and a CE mark for aortic regurgitation with the same system in 2013. In 2014 it began transfemoral procedures, through an artery in the leg, in clinical trials, and in 2015 it set up operations in the United Kingdom. The US pivotal trial for aortic regurgitation, ALIGN-AR, started in 2018 with a transfemoral valve made of porcine pericardial tissue; the company says it received a CE mark for that system in 2021, for both aortic regurgitation and aortic stenosis, and established its US operations and completed enrolment in ALIGN-AR in 2022.

The Trilogy system.

The product that carries the brand is the Trilogy transcatheter heart valve system. The company describes the valve as a self-expanding nitinol frame carrying porcine pericardial tissue treated with its proprietary Jasmine process, with a sealing ring and three “locators” that sit in the patient’s own valve cusps to align the new valve and attach it to the native leaflets. It is delivered on a dedicated catheter system with an 85-centimetre introducer sheath, which the company says is designed for single-action release.

The United States followed Europe in 2026. On 18 March 2026 JenaValve announced FDA approval of the Trilogy system; its timeline describes the approval as covering patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical valve replacement. On 1 April 2026, in a release datelined Irvine, California, the company announced its first commercial US cases, performed the same day at NewYork-Presbyterian/Columbia University Irving Medical Center, Cedars-Sinai Medical Center and Piedmont Heart Institute, and the official US launch. In that release JenaValve calls Trilogy the first and only transcatheter device in the United States with a dedicated indication for high-risk AR; that is the company’s own claim.

Clinical work continues alongside the launch. The company says new results from ALIGN-AR were published in The Lancet and presented at PCR London Valves in November 2025, that a Trilogy procedure was shown live at TCT 2025, and that the first patient was enrolled in its randomised ARTIST trial in July 2025. It describes its mission as raising awareness and transforming the treatment of severe aortic regurgitation, and it keeps a separate patient-education site about the condition.

How the category presents itself.

Cardiovascular device makers sell to a narrow audience: interventional cardiologists, electrophysiologists, cardiac surgeons, hospital buyers and regulators. Their visual language follows from that. A heart valve, a stent or a pacemaker is small, precise and usually hidden inside the body once it is in use, so the product photograph does much of the work. Valves, stents and leads tend to be shot in close-up on white or pale grey, lit to show struts, mesh and metal edges, with the device itself as the only subject.

The second register is the catheterisation laboratory. Brochures, websites and congress stands return again and again to the same scene: a patient table, a C-arm X-ray system arched over it, banks of monitors showing angiograms or mapping images, and clinicians in scrubs, lead aprons and caps. These pictures place the device in the room where it is used, without showing the patient’s body in detail.

Between the two sits illustration. Cutaway hearts, cross-sections of arteries and simplified diagrams of the conduction system explain where a valve sits, how a stent opens or how a lead reaches the heart. They are often rendered in reds and soft pinks against white, with the brand’s own colour kept for the device, the arrows and the type. Much of the copy is technical, built around product names, trial names and regulatory approvals as the companies state them.

Much of the category’s public life happens at medical congresses. TCT in the United States, EuroPCR in Paris and the ESC Congress of the European Society of Cardiology bring makers, clinicians and trade press together each year, and companies use them to show new devices and announce study results. The makers in this guide range from family-owned German engineering firms to Chinese groups with several listed subsidiaries, and their identities reflect that range more than any shared house style.

A deal that did not happen.

For a year and a half JenaValve looked set to become part of a much larger company. In July 2024 Edwards Lifesciences signed agreements to acquire both JenaValve and JC Medical, another developer of transcatheter valves for aortic regurgitation, MedTech Dive reported; the JC Medical purchase was completed in August 2024. In August 2025 the US Federal Trade Commission challenged the JenaValve deal, arguing that it would combine the only two companies conducting US clinical trials of a TAVR device for aortic regurgitation. In January 2026 the US District Court for the District of Columbia granted the FTC’s motion for an injunction blocking the transaction, and Edwards said it would not move forward with the purchase, adding that it disagreed with the ruling, MedTech Dive reported on 12 January 2026.

JenaValve Technology therefore went to market on its own. Its website names John Kilcoyne, who joined in 2019, as chief executive, and lists partners of venture investors including Andera Partners and Rosetta Capital on its board. The company says it operates in the United States and Europe and describes itself as the developer and manufacturer of the Trilogy system; its US releases carry an Irvine, California dateline.

The name ties the product to a place: the city and the university where, the company says, the concept began. The leadership it has assembled for the US launch is drawn largely from established heart-device companies; its chief technology officer, who joined in 2026, previously led transcatheter valve research and development at Medtronic, and its chief commercial officer, who joined in October 2020, spent many years at St. Jude Medical, according to the company’s website.

For a design guide, JenaValve shows how a single-product company builds a brand around one condition and one device. Compare Edwards Lifesciences, which agreed to buy it in 2024 and dropped the deal in 2026, and Medtronic, where its chief technology officer previously worked. For this guide we use a deep teal, ink, a nitinol silver and a pale cream with a serif, an unofficial interpretation; no product or logo is reproduced.

Keep JenaValve’s identity on hand — save it to a board in the Made Good inspiration library.