Teleflex (NYSE:TFX) has announced the enrollment of the first patient in its DUBSTENT DIABETES clinical trial, a landmark study designed to evaluate dual-device strategies for percutaneous coronary intervention (PCI) in patients living with diabetes mellitus.
The randomized, investigator-initiated study seeks to address one of the most persistent challenges in interventional cardiology: the disproportionately high rates of stent failure among diabetic patients. Despite decades of innovation in stent design and drug delivery, diabetes remains a significant risk factor for restenosis, thrombosis, and repeat interventions following PCI. Teleflex’s support for this trial reflects the company’s strategic emphasis on advancing evidence-based solutions for high-risk populations.
Trial design and objectives
The DUBSTENT DIABETES trial evaluates whether a dual-device strategy—combining a drug-coated balloon (DCB) angioplasty with a drug-eluting stent (DES)—can improve outcomes compared to single-device strategies. The study specifically targets patients with de novo coronary artery lesions, a common and high-stakes presentation in diabetic populations.
The trial introduces three main treatment arms:
DCB + DES combination therapy – using Teleflex’s Pantera Lux DCB catheter alongside the Orsiro Mission DES.
Single-device DCB therapy – where patients are treated only with the Pantera Lux DCB.
Single-device DES therapy – where patients are treated only with the Orsiro Mission DES.
To enhance the rigor of the DCB-only arm, the study also includes the Freesolve resorbable magnesium scaffold (RMS)as a bail-out option, enabling physicians to restore vessel patency while adhering to a leave-nothing-behind approach. This reflects growing interest in minimizing permanent implants in coronary arteries, especially for patients where future interventions may be likely.
The primary endpoint of the study is percentage diameter stenosis at six months, measured by quantitative coronary angiography (QCA). Secondary endpoints are designed to capture a comprehensive picture of patient outcomes, including all-cause mortality, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization, and patient-reported quality of life up to five years post-procedure.
Clinical importance for diabetes patients
Patients with diabetes mellitus present a unique challenge in interventional cardiology. Diabetes accelerates atherosclerosis, leads to more diffuse and calcified lesions, and impairs vascular healing. As a result, stent implantation in diabetic patients often results in higher rates of restenosis and thrombosis compared to non-diabetic populations.
Even the most advanced drug-eluting stents (DES), while effective, cannot fully overcome these biological disadvantages. Similarly, drug-coated balloons (DCBs), which deliver antiproliferative drugs without leaving behind a permanent scaffold, have shown promise but remain under study in complex patient populations like diabetics.
By directly comparing DCB-only, DES-only, and combination strategies, the DUBSTENT DIABETES trial could generate data that shapes future treatment guidelines. It also addresses a long-standing question in interventional cardiology: whether the synergy of drug delivery plus scaffold support yields better outcomes than either approach on its own in high-risk cohorts.
Enrollment and study sites
Investigators plan to enroll 120 diabetic patients across high-volume centers in Ireland, reflecting a strategic choice to leverage sites with deep expertise in PCI research. Randomization ensures that each treatment arm will be rigorously compared, with statistical power sufficient to detect meaningful differences in outcomes.
The trial’s design mirrors the growing emphasis on real-world applicability, balancing innovation with clinical pragmatism. Including RMS as a bail-out in the DCB arm recognizes the importance of flexibility for operators, while also advancing the discussion around whether “leave-nothing-behind” strategies can finally move from experimental concept to clinical reality.
Company perspective
Teleflex leaders positioned the study as part of their ongoing mission to support science that directly addresses gaps in patient care.
“We are committed to advancing evidence-based solutions for complex patient populations. We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI,” said Dr. Georg Nollert, VP, Medical Affairs for Vascular Intervention at Teleflex.
This alignment with investigator-led research signals Teleflex’s recognition that breakthrough innovations often require collaboration between clinicians, industry, and academic institutions. By sponsoring and facilitating the DUBSTENT DIABETES trial, Teleflex reinforces its role as a strategic partner in cardiovascular medicine, while also positioning its devices within an evidence-driven framework.
Broader implications
The trial comes at a time when global PCI practices are evolving. Clinicians are increasingly interested in dual-device strategies, bioresorbable scaffolds, and hybrid approaches that balance drug delivery with vessel preservation. For diabetic patients, who represent a disproportionate share of adverse PCI outcomes, the trial’s findings could directly influence daily practice in catheterization labs worldwide.
Should the DUBSTENT DIABETES study demonstrate superior outcomes with dual-device therapy, Teleflex could help set a new standard of care for diabetic patients with coronary artery disease—an achievement with both clinical and commercial significance.
Competitive landscape and Teleflex’s positioning in coronary interventions
The launch of the DUBSTENT DIABETES trial underscores how companies like Teleflex are navigating one of the most competitive and evolving landscapes in MedTech: coronary interventions for high-risk patients. With global PCI volumes growing and patient populations becoming more complex, manufacturers are racing to differentiate their products through new device designs, hybrid strategies, and bioresorbable technologies. Teleflex’s support for this investigator-led trial signals a deliberate effort to place itself at the center of this next wave of innovation.
The rise of drug-coated balloons (DCBs)
In recent years, drug-coated balloons (DCBs) have gained traction as a viable alternative to stent implantation. Unlike drug-eluting stents (DES), which leave a permanent scaffold inside the artery, DCBs deliver antiproliferative drugs directly to the vessel wall without leaving anything behind. This “leave-nothing-behind” philosophy appeals to clinicians concerned about late stent thrombosis, impaired vessel healing, and the challenges of future interventions in stented segments.
In Europe, DCBs are already more widely used, particularly in small-vessel disease and in-stent restenosis. Companies such as B. Braun, Medtronic, and Boston Scientific have invested heavily in DCB portfolios. The U.S., however, has been slower to embrace DCBs due to regulatory hurdles, with adoption limited to select indications. Trials like DUBSTENT DIABETES could accelerate acceptance in the American market, particularly if they show that DCBs offer significant benefits for diabetic patients.
Teleflex’s Pantera Lux DCB is a cornerstone of its strategy. By positioning it alongside the Orsiro Mission DES, the trial not only validates the balloon itself but also explores whether synergy between drug delivery and scaffoldingyields better results than either approach alone.
The enduring strength of drug-eluting stents (DES)
While DCBs are gaining momentum, drug-eluting stents (DES) remain the backbone of PCI worldwide. Continuous innovation has made DES safer and more effective than ever, with thinner struts, biocompatible polymers, and improved drug kinetics. Yet challenges persist in patients with diabetes, where vascular biology and systemic inflammation increase the likelihood of restenosis.
Competitors in the DES space include Abbott (Xience), Boston Scientific (Synergy Megatron, Promus Elite), Medtronic (Resolute Onyx), and Biotronik (Orsiro Mission). Teleflex’s decision to integrate the Orsiro Mission DES into DUBSTENT DIABETES is strategic—it allows investigators to benchmark outcomes against a stent already recognized for its ultra-thin struts and favorable clinical performance.
For Teleflex, the combination arm offers an opportunity to position itself not as a challenger to DES dominance, but as an innovator exploring hybrid strategies that could optimize outcomes in the most difficult patient populations.
The potential of bioresorbable scaffolds (BRS)
The inclusion of the Freesolve resorbable magnesium scaffold (RMS) as a bail-out option in the DCB-only arm reflects growing interest in bioresorbable scaffolds (BRS). Early-generation BRS faced setbacks due to safety concerns, but newer designs—particularly magnesium-based scaffolds—promise improved safety profiles and faster resorption times.
If successful, the use of RMS could demonstrate how BRS technology complements DCBs in a leave-nothing-behind strategy, offering structural support when needed while avoiding the permanent downsides of metallic stents. This positions Teleflex as a participant in the revival of BRS technologies, a field where Abbott (Absorb), Reva Medical, and Biotronik have historically experimented.
Competitive implications for Teleflex
Teleflex operates in a competitive environment dominated by MedTech giants with deep stent and balloon portfolios. By supporting a multi-device comparative trial, the company distinguishes itself in several ways:
Evidence-first positioning: Rather than marketing claims, Teleflex is investing in clinical data to guide treatment strategies. This approach resonates with physicians and regulators alike.
Focus on diabetics: By targeting one of the most difficult patient populations, Teleflex highlights its commitment to addressing real-world clinical challenges rather than low-hanging fruit.
Partnership-driven innovation: The investigator-led nature of the trial emphasizes collaboration with clinicians, ensuring practical relevance and credibility.
In doing so, Teleflex is not merely promoting its Pantera Lux DCB or aligning with Orsiro Mission DES—it is attempting to shape the future of PCI decision-making, where hybrid approaches may become standard for complex patients.
Market context: diabetes and PCI
Globally, more than 20–30% of patients undergoing PCI have diabetes, a proportion expected to grow alongside rising diabetes prevalence. These patients have higher rates of multi-vessel disease, calcified lesions, and poor healing, making them more prone to adverse outcomes post-stenting.
The unmet need is substantial, and any device strategy that demonstrably improves long-term outcomes in diabetics could reshape treatment guidelines and market share. For Teleflex, success in DUBSTENT DIABETES could translate into commercial advantages not just in Europe, where DCBs are more established, but also in the U.S., where regulatory acceptance of new device strategies is still evolving.
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