Teleflex Incorporated Initiates DUBSTENT DIABETES Trial to Evaluate Dual-Device Strategy for PCI in Diabetic Patients

Teleflex announces the first patient enrolled in the DUBSTENT DIABETES trial evaluating PCI in diabetic patients.

Quiver AI Summary

Teleflex Incorporated announced the enrollment of the first patient in the DUBSTENT DIABETES trial, a clinical study aimed at evaluating a dual-device strategy for percutaneous coronary intervention (PCI) in diabetic patients. This trial will compare the combined use of drug-coated balloon (DCB) angioplasty and drug-eluting stent (DES) implantation against single-device approaches, specifically in patients with de novo coronary artery lesions. The study, addressing the higher rates of stent failure in diabetic patients, will enroll 120 participants across Ireland, with the primary endpoint being the percentage diameter stenosis observed at six months. Secondary endpoints will include various cardiovascular events and quality of life measurements over five years. Teleflex is committed to advancing treatment options for complex patient populations and views this trial as a significant step in improving outcomes for diabetes patients undergoing PCI.

Potential Positives

Teleflex has initiated the DUBSTENT DIABETES trial, which aims to address the critical unmet need of improving treatment outcomes for diabetic patients undergoing percutaneous coronary intervention (PCI).
This trial features a dual-device strategy, potentially enhancing the efficacy of coronary interventions in a high-risk patient population, indicating Teleflex's commitment to innovative medical solutions.
The study is expected to provide significant insights into the safety and efficacy of combining drug-coated balloons and drug-eluting stents, which could shape future treatment strategies for diabetes patients.
Enrollment of 120 patients across high-volume centers in Ireland demonstrates robust support for the research and a strategic focus on expanding clinical evidence in key therapy areas.

Potential Negatives

Not all products referenced in the study are approved for use in the United States, which may limit market potential and adoption.
The need for a bail-out option like the Freesolve™ Resorbable Magnesium Scaffold indicates potential risk or limitations associated with the primary treatment methods being studied.
The statement that patients with diabetes continue to experience higher rates of stent failure may reflect negatively on the effectiveness of existing solutions offered by Teleflex.

FAQ

What is the DUBSTENT DIABETES trial?

The DUBSTENT DIABETES trial is a clinical study evaluating a dual-device strategy for PCI in diabetic patients.

What devices are being tested in the DUBSTENT DIABETES trial?

The trial tests a combination of drug-coated balloons and drug-eluting stents compared to single-device strategies.

How many patients will be enrolled in the study?

The study will enroll 120 patients with diabetes across high-volume centers in Ireland.

What are the primary and secondary endpoints of the trial?

The primary endpoint is percentage diameter stenosis at six months, while secondary endpoints include myocardial infarction and quality of life.

Who is leading the DUBSTENT DIABETES trial?

Professor Robert A. Byrne is the Coordinating Principal Investigator of the DUBSTENT DIABETES trial.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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REPRESENTATIVE LISA C. MCCLAIN has traded it 2 times. They made 1 purchase worth up to $15,000 on 07/16 and 1 sale worth up to $15,000 on 07/22.

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LIAM KELLY (Chairman, President & CEO) purchased 1,500 shares for an estimated $172,605
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Shagun Singh from RBC Capital set a target price of $135.0 on 08/01/2025
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Full Release

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 technology ¹ .

“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: I nvestigational 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.

References:
1. https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013302

Contacts:
Teleflex Lawrence Keusch
Vice President, Investor Relations and Strategy Development
[email protected]
610-948-2836