Recent clinical studies provide evidence to help shape the future of patient care

Boston Scientific has long been at the forefront of innovation in minimally invasive therapies, guided by a clear purpose: addressing healthcare's greatest challenges so patients can experience more of what truly matters - more time, more quality of life and more moments with the people they love. 

Across our portfolio, we are building an ecosystem of innovation around unmet patient needs, underpinned by rigorous pre-clinical and clinical research. By prioritising safety, effectiveness, equitable access and patient outcomes, we aim not only to advance technology but to shape the future of care. 

Clinical evidence as a foundation for progress  

Strong clinical evidence plays an important role in helping physicians make confident treatment decisions. As healthcare systems in EMEA evolve towards more personalised and value-based care, robust data plays a critical role in helping medical professionals understand how minimally invasive technologies can improve outcomes, streamline care pathways and enhance the patient experience. 

In recent weeks, Boston Scientific clinical trials presented at leading international medical congresses have contributed new insights across multiple therapy areas, including atrial fibrillation (AF), acute pulmonary embolism (PE) and benign prostatic hyperplasia (BPH). Together, they add to a growing body of evidence designed to support better-informed care for patients around the world. 

Long-term patient benefits for both health outcomes and quality of life 

One such trial, CHAMPION-AF, provides important insights into stroke protection in patients with AF. Because AF can allow blood to pool and clot in the heart, often in a pouch called the left atrial appendage, it significantly increases the risk of clots travelling to the brain and causing a stroke. More than six million Europeans are affected by AF, and its prevalence is estimated to at least double over the next 50 years as the population ages. ^1, 2

The trial evaluated left atrial appendage closure, a minimally invasive procedure that seals off the appendage, using the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) device compared with direct oral anticoagulants, the current standard of care for AF. Trial results demonstrated that WATCHMAN FLX met key safety and efficacy endpoints, and delivered comparable protection against stroke and systemic embolism, while significantly reducing bleeding risk over time. 

These findings are particularly relevant as physicians consider long-term treatment strategies and patients’ adherence, especially where bleeding risk may influence therapy decisions. By offering an alternative approach supported by robust clinical data, the trial helps enable more informed, shared decision-making between physicians and patients. 

Helping refine care pathways in acute conditions 

In acute pulmonary embolism, the HI-PEITHO trial added further clarity in an area where treatment decisions can be complex. The study assessed the use of ultrasound-assisted, catheter-directed thrombolysis using the EKOS™ Endovascular System alongside anticoagulation in patients with intermediate-risk PE.  

Results demonstrated a significant reduction in adverse clinical outcomes compared with anticoagulation alone (the current standard of care), without an increase in major bleeding. This evidence contributes to a more nuanced understanding of how and when to intervene. It supports physicians in identifying patients who may benefit from earlier, minimally invasive treatment, while reinforcing the importance of balancing efficacy and safety in acute care settings. 

This trial adds to a growing evidence base that is helping to broaden access to advanced therapies. As data are shared with healthcare providers, payers and policymakers, they contribute to inform guidelines and reimbursement decisions that can enable more patients to receive appropriate care. 

Broadening care that supports everyday quality of life 

In urology, findings from the VAPEUR trial further expanded the evidence base in benign prostatic hyperplasia (BPH), demonstrating that Rezūm™ Water Vapour Therapy provides superior BPH symptom relief versus combination therapy, measured by the International Prostate Symptom Score (IPSS), while preserving sexual function. 

The VAPEUR multi-centre randomised clinical study compares Rezūm Therapy to dual drug therapy, also referred to as combination therapy, for the treatment of symptomatic benign prostatic hyperplasia (BPH) in sexually active men. Combination therapy consists of two drugs, an alpha blocker and 5-alpha reductase inhibitor (5-ARI). 

Patient adherence to BPH treatment with medication is variable. Up to 70% of men treated with single or combination therapy discontinue treatment before one year, primarily due to adverse drug reactions.³ Some data suggests treatment with alpha blockers and/or 5-ARIs may increase the risk of heart failure, diabetes, depression and dementia.^{4, 5, 6, 7}

Data from the VAPEUR study demonstrates the effectiveness and safety of Rezūm Therapy in patients who would otherwise be directed to combination therapy, underscoring the value of adopting Rezūm Therapy into routine practice. It also demonstrates that Rezūm Therapy can serve as a potential first-line alternative to combination therapy, after alpha blockers fail, for the treatment of symptomatic BPH in sexually active men. 

As minimally invasive options continue to evolve, data from studies like VAPEUR help clinicians understand how therapies perform against other available options across diverse patient needs. The results may also help inform future discussions around the positioning of minimally invasive therapies as potential first-line treatment to support and inform updates to BPH guidance. 

Looking ahead: evidence that enables transformation 

Across these studies, a clear theme emerges. Clinical evidence is not only validating new technologies—it is helping to refine clinical decision making, inform guidelines and support broader access to innovative care. By addressing practical questions around safety, effectiveness and patient experience, these trials contribute to more confident and broader choices across the care pathway. 

Looking ahead, continued investment in clinical research will be critical as medtech plays an increasingly important role in addressing healthcare system pressures, enabling more personalised care and improving outcomes for patients. At Boston Scientific, we remain committed to advancing the science that helps shape what’s next in patient care. 

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