Philips enrolls first patient in U.S. clinical trial for innovative integrated single-device to treat peripheral artery disease
- 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 50% residual stenosis post-procedure. Patients will be followed for 12 months.
“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
Attachments
- THOR Integrated Device
- THOR First Patient Milestone Release_FINAL
TIN LIÊN QUAN
THỦ THUẬT HAY
Hướng dẫn cách thay đổi công cụ tìm kiếm trong trình duyệt Edge
Trong hệ điều hành Windows 10 vừa được Microsoft tung ra, một điểm thay đổi đáng chú ý là trình duyệt web Edge hoàn toàn mới đã được tích hợp bên trong. Tuy nhiên, trình duyệt này lại sử dụng công cụ tìm kiếm mặc định
Hướng dẫn thanh toán QR Pay trên Vietinbank iPay
Chỉ cần sử dụng camera điện thoại quét mã QR để thực hiện thanh toán mua sắm online vô cùng nhanh chóng.
Đây là 5 cách khắc phục ứng dụng Samsung Notes bị lỗi đơn giản, hiệu quả
Samsung Notes được biết đến là một ứng dụng không thể thiếu đối với những Samfan hay ghi chú trên điện thoại Samsung. Trong quá trình sử dụng bạn thường hay gặp một số lỗi phát sinh như: lỗi không vào được ứng dụng,
Không muốn tốn tiền 3G, hãy lưu ý những thiết lập này
Những tính năng tự động phát video, hay phát nhạc, video chất lượng cao trên facebook, youtube ... là những thủ phạm chính khiến tiền 3G hàng tháng của bạn tăng cao.
Cách tính các hàm số lượng giác trong Excel, RADIANS, DEGREES, COS
Gần đây chúng tôi có nhận được câu hỏi từ phía độc giả về cách tính các hàm số lượng giác trong Excel như thế nào. Bài viết dưới đây sẽ hướng dẫn các bạn cách tính các hàm số lượng giác trong Excel như RADIANS,
ĐÁNH GIÁ NHANH
Trên tay iMac Pro: Cấu hình siêu mạnh trong thân máy mỏng nhẹ, ít tốn điện
Bằng cách sử dụng CPU được Intel tùy biến riêng, SSD được chế tạo độc quyền cho iMac Pro hay các giải pháp nhà làm như con chip bảo mật T2, Apple đã có thể 'nhét' được một cấu hình siêu mạnh vào một thân máy mỏng nhẹ,
Đánh giá camera Google Pixel: tuyệt vời HDR+
Với thuật toán từ HDR+, Google Pixel đã vươn mình trở thành một trong những camera phone có khả năng chụp ảnh tốt nhất thế giới hiện nay
Thử nghiệm thời lượng pin Bphone 2017: sử dụng hỗn hợp hơn 19 tiếng, sạc rất nhanh
Thực tế thử nghiệm thì viên pin 3.000 mAh của Bphone 2017 chỉ giúp chiếc máy này hoạt động được gần 1 ngày chứ không phải 2 ngày như những gì nhà sản xuất công bố. Kết quả sau quá trình test cho thấy máy có thể on