First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients

By: Teleflex Incorporated via GlobeNewswire

September 11, 2025 at 06:30 AM EDT

WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary intervention (PCI) in patients with diabetes mellitus.

The DUBSTENT DIABETES trial will investigate the safety and efficacy of combining drug-coated balloon (DCB) angioplasty with drug-eluting stent (DES) implantation compared to single-device strategies DCB or DES only in diabetic patients with de novo coronary artery lesions. As a bail-out option, the FreesolveTM Resorbable Magnesium Scaffold (RMS) would be considered in the DCB only arm to assess the leave-nothing behind approach. The study addresses a critical unmet need, as patients with diabetes continue to experience higher rates of stent failure despite advances in DES technology¹.

“This trial explores a promising approach to improve outcomes in a high-risk population,” said Professor Robert A. Byrne, Coordinating Principal Investigator of the study and Director of Cardiology at Mater Private Network, Dublin, Ireland. “By combining the benefits of drug-coated balloons and sirolimus-eluting stents, we are interested to see the impact on restenosis and long-term vessel health in patients with diabetes.”

The DUBSTENT DIABETES trial will enroll 120 diabetes patients across high-volume centers in Ireland. Participants will be randomized to receive either:

A combination of the Pantera™ Lux™ DCB Catheter (which is part of the Lux™ family of Paclitaxel-coated balloons) and the Orsiro™ Mission™ DES
The Pantera™ Lux™ DCB Catheter alone
The Orsiro™ Mission™ DES alone

The primary endpoint is percentage diameter stenosis at six months, assessed by quantitative coronary angiography. Secondary endpoints include death, myocardial infarction, target lesion revascularization, target lesion thrombosis, target vessel revascularization, and quality of life up to five years.

“We are committed to advancing evidence-based solutions for complex patient populations,” said Prof. Dr. Georg Nollert, Vice President Medical Affairs for Vascular Intervention at Teleflex. “We are proud to support this important investigator-led study, which may help shape future treatment strategies for patients with diabetes undergoing PCI.”

About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in the world of healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Not all products may be available in all countries. The Pantera™ Lux™ Drug-Coated Balloon Catheter is not approved in United States and the Freesolve™ Resorbable Magnesium Scaffold (RMS) is limited to investigational use in the United States. Indications for use may vary by geographic location.

*Professor Byrne is a paid consultant of Teleflex Incorporated or its affiliates.

**Study sponsored by Teleflex Incorporated or its affiliates.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.

Freesolve™ RMS CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, Freesolve, LMA, Lux, Mission, Orsiro, Orsiro Mission, Pantera, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this press release is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative.