Philips enrolls first patient in U.S. clinical trial for innovative integrated single-device to treat peripheral artery disease
Philips announced enrollment of the first patient in the U.S. THOR IDE clinical trial, testing an innovative combined laser atherectomy and intravascular lithotripsy catheter. The device integrates two PAD treatments into a single solution, performed at the Cardiovascular Institute of the South in Louisiana on a 78-year-old male. The trial will enroll up to 155 patients at up to 30 U.S. sites to evaluate safety and efficacy in treating complex, calcified lesions. The study's primary endpoints include freedom from major adverse events within 30 days and achieving ≤50% residual stenosis post-procedure, with 12-month patient follow-up.
Philips ha annunciato l'arruolamento del primo paziente nello studio clinico THOR IDE negli Stati Uniti, testando un innovativo catetere per aterectomia laser combinata e litotripsia intravascolare. Il dispositivo integra due trattamenti per la PAD in una sola soluzione, eseguito presso l'Istituto Cardiovascolare del Sud in Louisiana su un uomo di 78 anni. Lo studio arruolerà fino a 155 pazienti in fino a 30 siti negli Stati Uniti per valutare la sicurezza e l'efficacia nel trattamento di lesioni complesse e calcificate. I principali obiettivi dello studio includono la libertà da eventi avversi maggiori entro 30 giorni e il raggiungimento di una stenosi residua ≤50% post-procedura, con un follow-up dei pazienti a 12 mesi.
Philips anunció la inclusión del primer paciente en el ensayo clínico THOR IDE en EE. UU., que prueba un innovador catéter combinado de aterectomía láser y litotricia intravascular. El dispositivo integra dos tratamientos para la PAD en una sola solución, realizado en el Instituto Cardiovascular del Sur en Louisiana en un hombre de 78 años. El ensayo incluirá hasta 155 pacientes en hasta 30 sitios en EE. UU. para evaluar la seguridad y eficacia en el tratamiento de lesiones complejas y calcificadas. Los principales objetivos del estudio incluyen la libertad de eventos adversos mayores en 30 días y lograr ≤50% de estenosis residual después del procedimiento, con un seguimiento de pacientes a 12 meses.
필립스는 미국에서 THOR IDE 임상 시험에 첫 번째 환자가 등록되었다고 발표했습니다. 이번 시험에서는 혁신적인 레이저 혈관 성형술 및 혈관 내 체외 파쇄 카테터를 테스트하고 있습니다. 이 장치는 PAD 치료를 단일 솔루션으로 통합하며, 루이지애나의 남부 심혈관 연구소에서 78세 남성을 대상으로 수행되었습니다. 본 시험은 최대 30개의 미국 사이트에서 최대 155명의 환자를 등록하여 복잡하고 석회화된 병변 치료의 안전성과 효능을 평가할 것입니다. 연구의 주요 목표는 30일 이내의 주요 부작용으로부터의 자유와 시술 후 ≤50%의 잔여 협착도를 달성하는 것이며, 12개월의 환자 추적 조사를 포함합니다.
Philips a annoncé l'inscription du premier patient dans l'essai clinique THOR IDE aux États-Unis, testant un cathéter combiné d'athérectomie au laser et de lithotritie intravasculaire innovant. L'appareil intègre deux traitements de la PAD dans une solution unique, réalisée à l'Institut Cardiovasculaire du Sud en Louisiane sur un homme de 78 ans. L'essai inscrira jusqu'à 155 patients dans jusqu'à 30 sites aux États-Unis pour évaluer la sécurité et l'efficacité dans le traitement de lésions complexes et calcifiées. Les principaux critères d'évaluation de l'étude incluent la liberté d'événements indésirables majeurs dans les 30 jours et l'obtention d'une sténose résiduelle ≤50 % après l'intervention, avec un suivi des patients de 12 mois.
Philips hat die Einschreibung des ersten Patienten in die US-Studie THOR IDE angekündigt, die einen innovativen Kombikathter für Laser-Atherektomie und intravasculaire Lithotripsie testet. Das Gerät integriert zwei PAD-Behandlungen in einer einzigen Lösung und wurde am Cardiovascular Institute of the South in Louisiana an einem 78-jährigen Mann durchgeführt. Die Studie wird bis zu 155 Patienten an bis zu 30 Standorten in den USA einschreiben, um die Sicherheit und Wirksamkeit bei der Behandlung komplexer, verkalkter Läsionen zu bewerten. Die primären Endpunkte der Studie umfassen die Freiheit von schweren unerwünschten Ereignissen innerhalb von 30 Tagen und das Erreichen einer ≤50% restlichen Stenose nach dem Eingriff, mit einer 12-monatigen Nachverfolgung der Patienten.
- First-of-its-kind device combining two treatments in one, potentially reducing procedural complexity
- Innovative laser-driven technology eliminates need for separate ultrasound catheter
- Potential to streamline complex interventions and reduce multiple hospital visits
- Large-scale clinical trial with up to 155 patients across 30 U.S. sites
- Device is still investigational and not commercially available
- Clinical trial results and FDA approval pending
- Study requires 12-month follow-up period before effectiveness can be confirmed
Insights
The initiation of the THOR IDE clinical trial for Philips' novel dual-function laser device represents a significant technological advancement in PAD treatment. This innovative device combines laser atherectomy and laser-based intravascular lithotripsy in a single catheter - a world first that could substantially streamline complex vascular procedures.
The trial's scope is substantial, targeting 155 patients across 30 U.S. sites. Key success metrics include freedom from major adverse events and achieving ≤
While the device shows promise, investors should note it's still in early clinical stages and faces a 12-month follow-up period. Success could position Philips competitively in the
This development strengthens Philips' position in the interventional devices segment, targeting a significant market opportunity in PAD treatment. The innovative single-device approach could offer compelling economic benefits to healthcare providers by:
- Reducing procedure time and complexity
- Potentially lowering procedural costs
- Minimizing inventory management needs
The technology represents a clear competitive advantage, as no other company currently offers a combined laser-based solution. If successful, this could help Philips capture market share from established players in both the atherectomy and lithotripsy segments, while potentially expanding the addressable market by making these procedures more accessible to a broader range of healthcare facilities.
- With a unique world-first ability to perform laser atherectomy and laser-based intravascular lithotripsy using a single device, Philips takes a major step forward in the treatment of peripheral artery disease (PAD)
- Cardiovascular Institute of the South successfully treats first patient in the U.S. using Philips’ innovative laser system, marking a milestone in advancing personalized care for PAD patients
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced enrollment of the first patient in the U.S. THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter developed by Philips, that integrates two critical PAD treatments into a single device. Procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, simplifying workflows and procedures and potentially reducing the risk and improving outcomes for patients who might otherwise face multiple complex interventions.
The Cardiovascular Institute of the South in Louisiana recently completed the first case using the new laser catheter. The care team there successfully treated a 78-year-old male with peripheral vascular disease using the Philips device.
“Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system,” said Drs. Craig Walker and McCall Walker of Cardiovascular Institute of the South in Louisiana. “This trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions.”
This ground-breaking first procedure not only marks the launch of the THOR IDE trial. It also showcases how this innovative new technology, which resulted from Philips’ powerful in-house development capabilities, can ease the patient experience by streamlining complex interventions into a single procedure, potentially reducing the need for multiple interventions and hospital visits.
The goal of this pivotal study is to evaluate the safety and efficacy of using this unique laser device — a first-of-its-kind solution that integrates laser atherectomy and intravascular lithotripsy in a single device to treat complex, calcified lesions in a single procedure for patients with peripheral artery disease (PAD), restoring blood flow to their legs.
Significantly simplifying the treatment workflow
PAD is a common and serious condition that affects millions of people worldwide, particularly older adults and those with diabetes or high cholesterol. It leads to reduced blood flow to the limbs, often resulting in severe pain, ulcers, and, in extreme cases, limb amputation [1]. Patients with calcified lesions represent a particularly challenging group, as traditional treatment options often involve multiple steps and devices, increasing procedural complexity and risk.
The Philips laser catheter integrates two critical PAD treatments into a single device, significantly simplifying the treatment workflow – atherectomy to remove atherosclerotic plaque from the internal surface of an artery, and intravascular lithotripsy to modify calcium deposits within the artery or disrupt calcium deposits in the artery wall. The unique and highly innovative feature of the Philips catheter is that both the atherectomy and lithotripsy are laser-driven. Compared to conventional intravascular lithotripsy devices, which require the use of a separate ultrasound catheter to create calcium-disrupting sonic shockwaves, the Philips device uses a pulsed laser to instantly vaporize fluid within the blood vessel to create bubbles that expand and then rapidly collapse, generating the required sonic waves as they do so.
Prospective, single-arm, multicenter study
The prospective, single-arm, multicenter study will enroll up to 155 patients at up to 30 sites in the U.S. Conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), it will assess the system's safety and effectiveness in achieving procedural success with a low rate of complications.
The study’s primary endpoints include freedom from major adverse events (MAEs) such as mortality, unplanned amputations, and clinically driven target lesion revascularization (CD-TLR) within 30 days (about four and a half weeks) of the procedure, as well as achieving less than or equal to
“This innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions. That makes this an exciting innovation milestone as we enroll the first patient in this important U.S. clinical trial,” said Dr. Genovese, MD, vascular surgeon and co-principal investigator of the THOR* trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania. “Integrating atherectomy and intravascular lithotripsy into a single device has the potential to revolutionize the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications.”
Stacy Beske, Business Leader, Philips Image Guided Therapy Devices, added: “A result of Philips’ extensive in-house innovation and development capabilities, our combined laser atherectomy and intravascular lithotripsy device reflects our commitment to providing physicians with the tools they need to tackle complex vascular challenges more efficiently and effectively, potentially transforming treatment paradigms for peripheral artery disease. Philips is dedicated to clinically validating its innovations through rigorous trials and does so in collaboration with strong clinical partners.”
The Philips laser atherectomy and intravascular lithotripsy system is currently investigational and not yet commercially available anywhere in the world, including the United States.
[1] Peripheral artery disease (PAD) - Symptoms and causes - Mayo Clinic
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