Preliminary Results from IDE Study on Ringer™ Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference
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.
Teleflex (NYSE: TFX) ha annunciato i risultati preliminari del suo studio Ringer™ PBC IDE durante la CTO Plus Conference, che indaga un nuovo catetere a pallone per la perfusione per la gestione delle perforazioni coronariche. Lo studio ha arruolato 30 partecipanti in quattro siti negli Stati Uniti.
Il Ringer™ PBC presenta un design a pallone elicoidale unico che consente il flusso sanguigno coronarico continuo durante l'inflazione. I risultati chiave hanno mostrato:
- Obiettivo primario di efficacia raggiunto nel 73,3% dei partecipanti (22/30)
- Consegna del dispositivo riuscita nel 86,7% dei casi (26/30)
- Controllo dell'extravasazione con perfusione nel 84,6% delle consegne riuscite (22/26)
Il dispositivo ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA per la gestione delle perforazioni coronariche. Dodici partecipanti hanno richiesto un trattamento con stent coperto dopo la procedura, uno ha necessitato di un intervento chirurgico d'emergenza e si sono verificati tre decessi nonostante il controllo dell'extravasazione. È stata presentata una domanda di premercato alla FDA.
Teleflex (NYSE: TFX) anunció resultados preliminares de su estudio Ringer™ PBC IDE en la CTO Plus Conference, que investiga un nuevo catéter de balón de perfusión para el manejo de perforaciones coronarias. El estudio incluyó a 30 participantes en cuatro sitios de EE. UU.
El Ringer™ PBC presenta un diseño de balón helicoidal único que permite el flujo sanguíneo coronario continuo durante la inflación. Los resultados clave mostraron:
- Se alcanzó el objetivo primario de eficacia en el 73,3% de los participantes (22/30)
- Entrega exitosa del dispositivo en el 86,7% de los casos (26/30)
- Control de extravasación con perfusión en el 84,6% de las entregas exitosas (22/26)
El dispositivo ha recibido la Designación de Dispositivo Innovador de la FDA para el manejo de perforaciones coronarias. Doce participantes requirieron tratamiento con stent cubierto después del procedimiento, uno necesitó cirugía de emergencia y se produjeron tres muertes a pesar del control de la extravasación. Se ha presentado una solicitud de premercado a la FDA.
Teleflex (NYSE: TFX)는 CTO Plus Conference에서 Ringer™ PBC IDE 연구의 예비 결과를 발표했습니다. 이 연구는 관상동맥 천공 관리를 위한 새로운 관류 풍선 카테터를 조사하고 있습니다. 연구에는 미국의 네 곳에서 30명의 참가자가 등록되었습니다.
Ringer™ PBC는 팽창 중 지속적인 관상동맥 혈류를 허용하는 독특한 나선형 풍선 디자인을 특징으로 합니다. 주요 결과는 다음과 같습니다:
- 참가자의 73.3% (22/30)에서 1차 유효성 목표 달성
- 86.7%의 경우(26/30)에서 성공적인 장치 전달
- 성공적인 전달의 84.6% (22/26)에서 관류로 외부 유출 제어
이 장치는 관상동맥 천공 관리를 위한 FDA의 혁신적인 장치 지정을 받았습니다. 12명의 참가자가 시술 후 덮개 스텐트 치료가 필요했으며, 1명은 응급 수술이 필요했고, 외부 유출이 통제되었음에도 불구하고 3명이 사망했습니다. FDA에 사전 시장 신청이 제출되었습니다.
Teleflex (NYSE: TFX) a annoncé des résultats préliminaires de son étude Ringer™ PBC IDE lors de la CTO Plus Conference, qui examine un nouveau cathéter à ballon de perfusion pour la gestion des perforations coronaires. L'étude a inclus 30 participants dans quatre sites aux États-Unis.
Le Ringer™ PBC présente un design de ballon hélicoïdal unique permettant un flux sanguin coronarien continu pendant le gonflage. Les résultats clés ont montré:
- Objectif d'efficacité principal atteint chez 73,3% des participants (22/30)
- Livraison réussie du dispositif dans 86,7% des cas (26/30)
- Contrôle de l'extravasation avec perfusion dans 84,6% des livraisons réussies (22/26)
Le dispositif a reçu la désignation de Dispositif Innovant de la FDA pour la gestion des perforations coronaires. Douze participants ont nécessité un traitement par stent couvert après la procédure, un a nécessité une chirurgie d'urgence et trois décès ont été signalés malgré le contrôle de l'extravasation. Une demande de mise sur le marché a été soumise à la FDA.
Teleflex (NYSE: TFX) gab die vorläufigen Ergebnisse seiner Ringer™ PBC IDE-Studie auf der CTO Plus Conference bekannt, die einen neuartigen Perfusionsballonkatherer zur Behandlung von koronaren Perforationen untersucht. An der Studie nahmen 30 Teilnehmer an vier Standorten in den USA teil.
Der Ringer™ PBC verfügt über ein einzigartiges spiralförmiges Ballon-Design, das während der Inflation einen kontinuierlichen koronaren Blutfluss ermöglicht. Die wichtigsten Ergebnisse zeigten:
- Primäres Wirksamkeitsziel wurde bei 73,3% der Teilnehmer (22/30) erreicht
- Erfolgreiche Geräteeinführung in 86,7% der Fälle (26/30)
- Kontrolle der Extravasation mit Perfusion in 84,6% der erfolgreichen Einführungen (22/26)
Das Gerät erhielt von der FDA die Zulassung als Durchbruchgerät zur Behandlung von koronaren Perforationen. Zwölf Teilnehmer benötigten nach dem Eingriff eine Behandlung mit einem überzogenen Stent, einer benötigte eine Notoperation, und trotz kontrollierter Extravasation kam es zu drei Todesfällen. Ein Antrag auf Marktzulassung wurde bei der FDA eingereicht.
- 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
- 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
Insights
Teleflex's Ringer™ PBC IDE study results represent a moderately positive development in the company's interventional cardiology portfolio. The preliminary data showed the device achieved its primary efficacy endpoint in
These results are clinically meaningful given the current options for managing coronary perforations during PCIs. Coronary perforations are rare but potentially catastrophic complications, occurring in approximately
The FDA's Breakthrough Device Designation already signals regulatory recognition of this unmet need. The recent premarket application submission suggests Teleflex believes these results support commercialization. If approved for this new indication, the Ringer™ PBC would expand beyond its current more use for balloon dilatation.
While the 30-patient sample size is modest, these results from a multicenter study provide reasonable preliminary evidence. The study's adverse events (3 deaths, 1 emergency surgery) must be viewed in context of the already high-risk nature of coronary perforation cases rather than as direct device limitations. The fact that 12 patients required covered stents following Ringer™ PBC use suggests it may serve as a bridge to definitive therapy rather than a complete solution in many cases.
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 (
"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:
- 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
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