Preliminary Results from IDE Study on Ringer™ Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference

Rhea-AI Summary

Teleflex (NYSE: TFX) announced preliminary results from its Ringer™ PBC IDE study at the CTO Plus Conference, investigating a novel perfusion balloon catheter for managing coronary perforations. The study enrolled 30 participants across four US sites.

The Ringer™ PBC features a unique helical balloon design allowing continuous coronary blood flow during inflation. Key results showed:

• Primary efficacy endpoint achieved in 73.3% of participants (22/30)
• Successful device delivery in 86.7% of cases (26/30)
• Control of extravasation with perfusion in 84.6% of successful deliveries (22/26)

The device has received FDA's Breakthrough Device Designation for coronary perforation management. Twelve participants required covered stent treatment post-procedure, one needed emergency surgery, and three deaths occurred despite controlled extravasation. A premarket application has been submitted to FDA.

Positive

• Received FDA Breakthrough Device Designation, potentially accelerating approval process
• High device delivery success rate of 86.7%
• Strong extravasation control rate of 84.6% in successful deliveries
• Premarket application submitted to FDA

Negative

• Primary efficacy endpoint missed in 26.7% of cases
• Three patient deaths occurred during the trial
• Additional interventions required in 12 cases (covered stents)
• One emergency surgery needed due to complications

Prospective Multicenter Study Investigates Ringer™ PBC for Management of Coronary Perforations

WAYNE, Pa., March 27, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the preliminary results from its Ringer™ PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York by the study’s principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.*

Ringer™ PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter with a unique helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood flow during prolonged inflations.¹

The Ringer™ PBC study is a limited prospective, multi-center, single-arm IDE study, undertaken at four sites in the United States investigating the Ringer™ PBC for the management of emergent coronary perforations that develop during percutaneous coronary intervention (PCI) procedures. The study enrolled 30 participants, and analysis was performed based upon intention-to-treat. The primary efficacy endpoint required successful Ringer™ PBC delivery and inflation at the perforation site, control of extravasation (defined as residual Ellis grade 0 or 1), and preservation of antegrade coronary flow (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3).

Of 30 participants enrolled, the primary efficacy endpoint was observed in 22 participants (73.3%), with successful Ringer™ PBC delivery in 26 participants (86.7%). Among those participants with successful delivery, control of extravasation with perfusion was achieved in 22 participants (84.6%). Twelve participants were treated with a covered stent following perforation management with the Ringer™ PBC. One participant required emergency surgery for complications of pericardiocentesis, and three participants died despite control of extravasation from the index perforation.

"I believe these preliminary study results are important,” said Dr. Kandzari. “Treatment options for patients with coronary artery perforations during PCI cases have been limited to date, and this trial points the way to developing dedicated devices.”

For the investigational use of the management of coronary perforations, Ringer™ PBC was granted the FDA’s Breakthrough Device Designation, a program intended to provide patients and healthcare providers with timely access for certain medical devices that could potentially provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and DeNovo marketing authorizations.

"Teleflex is committed to generating the clinical evidence to help physicians make confident decisions when selecting the right products for their patients’ needs,” said Teleflex Medical Director, Christopher Buller, MD.

Ringer™ PBC is currently indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion. The Ringer PBC in this study is an investigational device and not available for sale. Data from the study is intended to support a premarket application recently submitted to FDA.

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 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.

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.

*Dr. Kandzari is a paid consultant of Teleflex Incorporated or its affiliates.

References:

1. Prolonged Balloon inflation is defined as balloon inflation equal to or greater than one minute. Data on file at Teleflex.
   

CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, Quik-Clot, Ringer, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. 

© 2025 Teleflex Incorporated. All rights reserved. MC-010629 Rev 0.

Contacts:

For Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610.948.2836

FAQ

What were the success rates of the Ringer PBC IDE study for TFX's coronary perforation device?

The study showed 73.3% primary efficacy endpoint achievement, 86.7% successful device delivery, and 84.6% control of extravasation with perfusion in successful deliveries.

How many complications occurred in TFX's Ringer PBC trial?

Among the 30 participants, 12 needed covered stents, 1 required emergency surgery, and 3 deaths occurred despite controlled extravasation.

What is the current FDA status of Teleflex's Ringer PBC device?

The device has received FDA Breakthrough Device Designation and a premarket application has been submitted to FDA.

How many sites and patients were involved in TFX's Ringer PBC IDE study?

The study was conducted at 4 US sites with 30 enrolled participants.