CroíValve appoints structural heart executive Jaime Wheeler as Lucy O’Keeffe becomes COO

CroíValve has appointed structural heart executive Jaime Wheeler as chief executive officer as the Irish medical device company prepares to expand clinical development of its DUO Adapt transcatheter tricuspid coaptation valve system. Wheeler succeeds company co-founder Lucy O’Keeffe, who will move into the chief operating officer role and remain a board member, preserving operational and technical continuity during the leadership transition. The appointment follows CroíValve’s recent expansion of its Series B financing and the planned enlargement of the TANDEM II clinical study across the United States and Europe. The central challenge for the new leadership team will be converting promising early clinical evidence and fresh funding into the larger, reproducible dataset required for regulatory approval and commercial adoption.

Why has CroíValve appointed Jaime Wheeler at this stage of DUO Adapt development?

CroíValve’s leadership change appears closely aligned with the company’s transition from founder-led technology development into a more complex phase of multinational clinical execution, regulatory planning and market preparation.

Wheeler brings more than 25 years of medical device and pharmaceutical industry experience, including 12 years at Edwards Lifesciences. She most recently served as senior vice president of global clinical affairs for the company’s transcatheter heart valve business, where CroíValve said she helped advance clinical evidence supporting several structural heart therapies, including the PARTNER trial programme. Her background also includes managing international operations, supporting mergers and acquisitions and working across clinical research, market access and patient representation.

That experience is relevant because CroíValve is entering a stage in which the quality of the technology alone will not determine the company’s prospects. Management must coordinate clinical investigators across multiple countries, work through regulatory requirements, establish scalable manufacturing processes, generate evidence that convinces physicians and prepare health economic arguments for hospitals and payers.

The appointment therefore represents more than a conventional executive succession. It places an executive familiar with the regulatory and clinical architecture of the structural heart market at the centre of CroíValve’s next growth phase.

CroíValve chairman Bernard Collins indicated that Wheeler’s record of helping guide novel technologies towards the market would support the company as it expands its United States presence and broader international activities. He also credited O’Keeffe with leading the business through product development and initial clinical validation.

How does Lucy O’Keeffe’s move to chief operating officer protect execution continuity?

O’Keeffe’s move from chief executive officer to chief operating officer reduces one of the most common risks associated with a leadership transition at a clinical-stage medical device company: the loss of institutional knowledge.

As a co-founder, O’Keeffe has helped guide CroíValve from its origins as a Trinity College Dublin spinout through early financing rounds, first-in-human procedures, United States regulatory engagement and the initiation of the TANDEM II study. She has also been closely involved in developing the company’s relationships with investors, clinicians, engineers and regulatory specialists.

Moving O’Keeffe into an operating role allows CroíValve to add Wheeler’s clinical commercialization experience without breaking continuity across product development, manufacturing and trial execution. That structure could be particularly valuable as the company increases the number of clinical sites and prepares the DUO Adapt System for a potentially broader patient population.

The effectiveness of the arrangement will still depend on clearly defined authority and decision-making responsibilities. Founder-to-professional-chief-executive transitions can create ambiguity when strategic oversight and operational control overlap. CroíValve’s decision to retain O’Keeffe as chief operating officer and board member suggests it is seeking a collaborative structure rather than a complete change in direction.

O’Keeffe said the company had reached a stage at which leadership with experience bringing transcatheter devices to market would be valuable. Her continued involvement should also reassure investors that the technical strategy and clinical rationale behind DUO Adapt are not being abandoned as the company becomes more commercially focused.

Why does CroíValve’s expanded funding make the leadership transition more significant?

The chief executive appointment comes approximately one month after CroíValve announced an additional $27 million of funding to support an enlarged TANDEM II study.

The June 2026 financing included a $20 million Series B expansion and $7 million from European Innovation Council and Disruptive Technologies Innovation Fund grant financing. CroíValve said the transaction increased total Series B equity funding to $36 million and brought the combined total, including grants, to $43 million. New investors included BGF and the European Innovation Council, while existing investors such as the MedTech Syndicate also participated.

This capital gives the new leadership team greater flexibility to add trial sites, enrol more patients, refine the DUO Adapt System and build the infrastructure required for later regulatory submissions. However, access to $43 million of equity and grant financing does not remove the capital intensity of developing an implantable structural heart device.

Larger studies require investigator training, clinical monitoring, independent imaging assessment, data management, regulatory support and long-term follow-up. Manufacturing must also move towards reproducible quality standards long before commercial approval becomes possible.

Wheeler’s initial capital allocation decisions will consequently be important. CroíValve must balance the desire to accelerate enrolment with the need to generate consistent clinical results and maintain sufficient financial runway for subsequent studies.

The expanded investor group may also increase expectations around timelines and measurable progress. The next financing decision is likely to depend not simply on the number of patients treated, but on whether DUO Adapt demonstrates predictable implantation, durable reduction in tricuspid regurgitation and meaningful improvement in patient function.

What does the TANDEM II study need to prove before commercialization becomes realistic?

The DUO System is being evaluated in TANDEM II, a prospective, multicentre, non-randomized early feasibility study involving patients with severe or greater symptomatic tricuspid regurgitation.

The public clinical trial record, last verified in May 2026, lists an estimated enrolment of 15 participants and an estimated primary completion date of December 2027. CroíValve subsequently said in June that the trial would be expanded beyond the 15 patients already treated and would add further sites in the United States and Europe. The registry may therefore require updating as the enlarged study design is implemented.

The study’s primary safety measure examines freedom from device-related or procedure-related major adverse events at 30 days, including death, disabling stroke, myocardial infarction, severe bleeding, renal failure requiring dialysis and major cardiac structural complications. Participants are expected to be followed for as long as five years, although the early feasibility programme is not designed by itself to establish the evidence base normally required for broad commercial approval.

CroíValve previously reported six-month results from 10 patients enrolled in its TANDEM I first-in-human study. According to the company, tricuspid regurgitation was reduced to moderate or less in more than 85% of patients, while functional capacity and quality-of-life measures improved. The company also reported 100% survival at six months and no arrhythmia or conduction disorder requiring permanent pacing within that small group.

Those findings provide an encouraging early signal, but the patient number remains limited. The enlarged TANDEM II programme must demonstrate that the procedure can be reproduced across more hospitals, operators and anatomical presentations. It will also need to establish whether early reductions in regurgitation are sustained and translate into durable clinical improvement.

For Wheeler, one of the most important tasks will be converting an innovative engineering proposition into a disciplined clinical evidence programme that regulators, physicians and investors can evaluate with confidence.

How is DUO Adapt positioned within the increasingly competitive tricuspid valve market?

CroíValve is developing DUO Adapt for a structural heart market that has moved rapidly from limited therapeutic options to active commercial competition.

Abbott Medical received United States Food and Drug Administration approval for the TriClip G4 System in April 2024. TriClip uses transcatheter edge-to-edge repair to attach portions of the native tricuspid valve leaflets and reduce regurgitation. Edwards Lifesciences received approval for the EVOQUE Tricuspid Valve Replacement System in February 2024 for selected patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy.

These approvals validate physician demand for transcatheter tricuspid interventions, but they also raise the competitive threshold facing CroíValve. By the time DUO Adapt approaches a pivotal study or regulatory submission, leading structural heart companies may have accumulated years of commercial experience, physician relationships and post-market data.

CroíValve is attempting to differentiate its system through an adaptive coaptation approach. The device places a coaptation valve between the native tricuspid leaflets and uses an anchoring system designed to avoid interaction with critical structures inside the right heart. CroíValve says the system is intended to accommodate large annular dimensions, wide coaptation gaps, cardiac implantable electronic device leads and advanced disease presentations that may be difficult for some alternative therapies.

The DUO Adapt version is designed to fill larger and more complex leak shapes, with CroíValve reporting early use in leaks measuring as much as 35 millimetres. These capabilities could give the platform a role among patients whose anatomy limits the effectiveness of leaflet repair or makes full valve replacement less suitable.

However, CroíValve’s competitive claims must ultimately be demonstrated through clinical evidence rather than engineering rationale alone. Physicians will compare residual regurgitation, procedural reliability, imaging requirements, implant durability, adverse events and patient recovery with existing repair and replacement systems.

What are the next measurable tests for Jaime Wheeler and the CroíValve strategy?

Wheeler joins CroíValve with stronger financing, an active multicentre clinical programme and early evidence supporting the DUO concept. The appointment improves the company’s leadership depth at a point when regulatory planning and clinical execution are becoming more demanding.

What remains unresolved is whether DUO Adapt can produce consistent results across a larger and more diverse patient population. The company must also show that its intended procedural simplicity can be maintained outside the small group of specialist physicians involved in early development.

The next measurable proof points will include confirmation of the enlarged TANDEM II study design, additional clinical sites, patient enrolment progress, procedural success rates and follow-up results. Updates to the public trial record may provide further clarity about enrolment targets and completion timelines.

Longer term, CroíValve will need to define the clinical pathway beyond early feasibility. That could include a larger pivotal study, continued dialogue with the United States Food and Drug Administration and a clearer regulatory strategy for Europe.

The leadership transition therefore strengthens CroíValve’s ability to prepare for commercialization, but commercialization itself remains several evidence-generating steps away. Wheeler’s most important test will be whether the company can preserve the technical flexibility that distinguishes DUO Adapt while imposing the operational discipline required to move an investigational device towards regulatory approval.

What are the key takeaways from CroíValve’s appointment of Jaime Wheeler as CEO?

• CroíValve has appointed former Edwards Lifesciences executive Jaime Wheeler as chief executive officer.
• Co-founder Lucy O’Keeffe has moved into the chief operating officer role and remains a board member.
• The transition adds structural heart clinical and commercialization experience while preserving operational continuity.
• Wheeler previously led global clinical affairs for the Edwards Lifesciences transcatheter heart valve business.
• The appointment follows CroíValve’s expansion of Series B and grant financing to a combined $43 million.
• Funding will support an enlarged TANDEM II study across the United States and Europe.
• DUO Adapt is designed to treat complex tricuspid regurgitation while preserving the native valve apparatus.
• Early clinical findings are encouraging, but the evidence remains based on small patient populations.
• Abbott Medical and Edwards Lifesciences already have approved tricuspid intervention systems in the United States.
• Enrolment progress, multicentre reproducibility and longer-term clinical outcomes will determine whether CroíValve can advance towards commercialization.