Teleflex Expands Interventional Cardiology Portfolio with FDA 510(k) Clearance of the Ringer™ Perfusion Balloon Catheter
Teleflex Incorporated (NYSE: TFX) has received FDA 510(k) clearance for its Ringer™ Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon. This innovative device features a unique helical balloon that allows for continuous coronary blood flow during prolonged inflations. The Ringer™ PBC is indicated for balloon dilatation of coronary artery or bypass graft stenoses where distal blood perfusion is desired during inflation.
The Ringer PTCA Clinical Study showed that inflation of the Ringer™ PBC for 60 seconds or more was well-tolerated in most patients vulnerable to procedural ischemia. Teleflex plans a market release in August 2024, marking a significant advancement in interventional cardiology and demonstrating the company's commitment to addressing unmet clinical needs.
Teleflex Incorporated (NYSE: TFX) ha ricevuto l'autorizzazione 510(k) della FDA per il suo catetere di perfusione Ringer™ (PBC), l'unico pallone di perfusione per angioplastica coronarica percutanea disponibile in commercio. Questo dispositivo innovativo presenta un pallone elicoidale unico che consente un flusso sanguigno coronarico continuo durante le inflazioni prolungate. Il Ringer™ PBC è indicato per la dilatazione del pallone in stenosi delle arterie coronarie o dei bypass nei quali è desiderato un perfusione sanguigna distale durante l'inflazione.
Lo studio clinico Ringer PTCA ha dimostrato che l'inflazione del Ringer™ PBC per 60 secondi o più è stata ben tollerata nella maggior parte dei pazienti vulnerabili all'ischemia procedurale. Teleflex prevede un lancio sul mercato nell'agosto 2024, segnando un avanzamento significativo nella cardiologia interventistica e dimostrando l'impegno dell'azienda nel soddisfare esigenze cliniche insoddisfatte.
Teleflex Incorporated (NYSE: TFX) ha recibido la autorización 510(k) de la FDA para su catéter de perfusión Ringer™ (PBC), el único balón de perfusión para angioplastia coronaria percutánea disponible comercialmente. Este dispositivo innovador cuenta con un balón helicoidal único que permite un flujo sanguíneo coronario continuo durante inflaciones prolongadas. El Ringer™ PBC está indicado para la dilatación de balón en estenosis de arterias coronarias o injertos de bypass donde se desea una perfusión sanguínea distal durante la inflación.
El estudio clínico Ringer PTCA mostró que la inflación del Ringer™ PBC durante 60 segundos o más fue bien tolerada en la mayoría de los pacientes vulnerables a la isquemia del procedimiento. Teleflex planea un lanzamiento al mercado en agosto de 2024, marcando un avance significativo en la cardiología intervencionista y demostrando el compromiso de la compañía para abordar necesidades clínicas insatisfechas.
Teleflex Incorporated (NYSE: TFX)는 Ringer™ 관류 풍선 카테터(PBC)에 대해 FDA 510(k) 승인을 받았습니다. 이는 상업적으로 이용 가능한 유일한 경피적 관상동맥 성형술(PTCA) 관류 풍선입니다. 이 혁신적인 기기는 독특한 나선형 풍선을 특징으로 하여 장시간 팽창 동안 지속적인 관상동맥 혈류를 가능하게 합니다. Ringer™ PBC는 팽창하는 동안 원거리 혈액 관류가 필요한 관상동맥 또는 우회 이식 편협증의 풍선을 확장하는 데 적합합니다.
Ringer PTCA 임상 연구에 따르면 Ringer™ PBC를 60초 이상 팽창시키는 것이 절차적 허혈에 취약한 대부분의 환자에게 잘 견뎌졌습니다. Teleflex는 2024년 8월에 시장 출시를 계획하고 있으며, 이는 중재적 심장학의 중요한 진전을 의미하며, 회사가 충족되지 않은 임상적 요구를 해결하기 위한 의지를 보여줍니다.
Teleflex Incorporated (NYSE: TFX) a obtenu l'autorisation 510(k) de la FDA pour son cathéter de perfusion Ringer™ (PBC), le seul ballon de perfusion pour angioplastie coronarienne percutanée disponible sur le marché. Cet appareil innovant présente un ballon hélicoïdal unique qui permet un flux sanguin coronarien continu pendant des gonflages prolongés. Le Ringer™ PBC est indiqué pour la dilatation par ballonnet des sténoses des artères coronaires ou des greffons de pontage, où une perfusion sanguine distale est souhaitée pendant le gonflage.
Une étude clinique sur le Ringer PTCA a montré que le gonflage du Ringer™ PBC pendant 60 secondes ou plus était bien toléré par la plupart des patients vulnérables à l'ischémie induite par la procédure. Teleflex prévoit un lancement sur le marché en août 2024, marquant une avancée significative dans la cardiologie interventionnelle et démontrant l'engagement de l'entreprise à répondre aux besoins cliniques non satisfaits.
Teleflex Incorporated (NYSE: TFX) hat die FDA-510(k)-Zulassung für seinen Ringer™ Perfusionsballonkatherer (PBC) erhalten, dem einzigen kommerziell verfügbaren percutanen transluminalen Koronarangioplastie (PTCA) Perfusionsballon. Dieses innovative Gerät verfügt über einen einzigartigen spiralförmigen Ballon, der einen kontinuierlichen Blutfluss im Herzen während längerer Aufblähungen ermöglicht. Der Ringer™ PBC ist für die Ballondilatation von Stenosen der Koronararterien oder Bypass-Transplantaten geeignet, bei denen während der Aufblähung eine distale Blutversorgung gewünscht wird.
Die Ringer PTCA-Studie ergab, dass die Aufblähung des Ringer™ PBC für 60 Sekunden oder länger von den meisten Patienten, die anfällig für prozedural bedingte Ischämie sind, gut vertragen wurde. Teleflex plant eine Markteinführung im August 2024, was einen bedeutenden Fortschritt in der interventionellen Kardiologie darstellt und das Engagement des Unternehmens zeigt, unerfüllte klinische Bedürfnisse anzugehen.
- FDA 510(k) clearance received for Ringer™ Perfusion Balloon Catheter
- Unique helical balloon design allows continuous coronary blood flow during prolonged inflations
- Clinical study demonstrated good tolerance in patients vulnerable to procedural ischemia
- market release planned for August 2024
- None.
Insights
The FDA 510(k) clearance of Teleflex's Ringer™ Perfusion Balloon Catheter (PBC) represents a significant advancement in interventional cardiology. This device addresses a critical need in Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures by allowing continuous coronary blood flow during prolonged balloon inflations.
Key features of the Ringer™ PBC include:
- A unique helical balloon design that forms a hollow cylinder when inflated
- A large central perfusion lumen for maintaining blood flow
- Compatibility with 0.014" guidewires
- Potential for delivering secondary devices through the lumen
The device's ability to maintain distal blood perfusion during balloon inflation is a significant improvement over traditional PTCA balloons. This feature could potentially reduce the risk of ischemia-related complications during procedures, especially in patients who are vulnerable to procedural ischemia.
Furthermore, the device's design opens up new possibilities for procedural innovation. The ability to deliver secondary devices through the central lumen could lead to more efficient and less invasive treatment strategies in complex coronary interventions.
While the initial market release is , the long-term impact of this device on interventional cardiology practices could be substantial. It has the potential to improve patient outcomes, reduce procedure times and possibly expand the range of treatable coronary lesions.
The FDA 510(k) clearance of Teleflex's Ringer™ Perfusion Balloon Catheter (PBC) is a positive development for the company's interventional cardiology portfolio. This approval could potentially strengthen Teleflex's position in the competitive medical device market, particularly in the coronary intervention segment.
Key financial implications to consider:
- Market Expansion: The Ringer™ PBC enters a niche but potentially lucrative market segment. As the "only commercially available" PTCA perfusion balloon, it could capture a significant market share.
- Revenue Growth: While initial release is , successful adoption could drive revenue growth in Teleflex's interventional segment over time.
- R&D Investment: The successful development and approval of this innovative device demonstrate Teleflex's commitment to R&D, which could attract investor interest.
- Competitive Advantage: The unique features of the Ringer™ PBC could provide Teleflex with a competitive edge in the interventional cardiology market.
However, investors should also consider potential challenges:
- initial release may result in slower-than-expected revenue impact
- Adoption rates among interventional cardiologists will be important for long-term success
- Potential for increased marketing and training expenses to promote the new technology
Overall, this FDA clearance aligns with Teleflex's strategy of expanding its high-value consumables portfolio and could contribute positively to the company's long-term growth prospects in the medical technology sector.
This milestone highlights Teleflex’s commitment to providing interventionalists with new tools specifically engineered to address unmet clinical needs.
WAYNE, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Ringer™ Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon.1
The Ringer™ PBC is a rapid-exchange 0.014” compatible catheter with a unique helical balloon at its working end. When inflated, this balloon approximates a hollow cylinder with a large central perfusion lumen. These characteristics allow for continuous coronary blood flow during prolonged inflations.2 The Ringer™ PBC is 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. In addition, during PTCA the lumen serves as a passage for delivery of secondary devices creating new opportunities for procedural innovation.
"The Ringer PTCA Clinical Study demonstrated that inflation of the Ringer™ PBC for 60 seconds or more was well tolerated in the majority of patients who are vulnerable to procedural ischemia,3" said Kathleen Kearney, MD, Principal Investigator of the Ringer PTCA Clinical Study and Interventional Cardiologist at the University of Washington. "We have been eagerly awaiting the arrival of the Ringer™ PBC because of the potential its unique properties have to contribute to patient safety and evolve our practice in the most complex PTCA cases."
The Ringer™ Perfusion Balloon Catheter will enter a limited market release phase in August of 2024.
"The FDA 510(k) clearance of the Ringer™ Perfusion Balloon Catheter signifies a crucial achievement in Teleflex's commitment to advancing medical innovation and improving patient outcomes,” said Teleflex Medical Director, Christopher Buller, MD. “We listen carefully to the challenges that interventionalists face daily and are proud, once again, to introduce a solution for unmet needs with this revolutionary PTCA perfusion balloon.”
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™, 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.
References:
- Data on file at Teleflex. Applicable to the US Market.
- Prolonged Balloon inflation is defined as balloon inflation equal to or greater than one minute. Data on file at Teleflex.
- Data of File at Teleflex. Ringer Perfusion Balloon Catheter Percutaneous Intervention (PTCA) Clinical Study. Symptoms of ischemia include chest pain, ECG changes, and hemodynamic changes.
CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, Quik-Clot, Ringer, 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 document is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative.
© 2024 Teleflex Incorporated. All rights reserved. MC-009863 Rev 0.
Contacts:
For Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610.948.2836
FAQ
What is the Ringer™ Perfusion Balloon Catheter (PBC) by Teleflex (TFX)?
When will Teleflex (TFX) release the Ringer™ Perfusion Balloon Catheter?
What were the results of the Ringer PTCA Clinical Study for Teleflex's (TFX) new catheter?
How does the Ringer™ Perfusion Balloon Catheter by Teleflex (TFX) differ from other PTCA balloons?
