Hotline 24/7: 0909384389

Share links:

Five-year patient-level data confirm safety of Passeo-18 Lux paclitaxel DCB

Ngày 29/04/2022 03:46 | Lượt xem: 874

New long-term data presented at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK) demonstrate the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated balloon (DCB) for the treatment of peripheral arterial disease (PAD) in infrainguinal arteries.

The independent analysis was led and presented by Ron Waksman (Georgetown University and MedStar Washington Hospital Center, Washington DC, USA). Individual patient-level data were pooled from three trials in the Passeo-18 Lux DCB clinical programme: the BIOLUX P-I and P-II randomised controlled trials (RCTs) and the BIOLUX P-III all-comers registry. Five-year follow-up data from 943 patients treated with Passeo-18 Lux DCB and 66 patients treated with percutaneous transluminal angioplasty (PTA) were evaluated.

The analysis showed that the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with an increase in all-cause mortality at five years compared to standard PTA (33.56% for DCB vs. 43.79% for PTA; p=0.47), a press release reveals.

“Our recent analysis adds to the body of long-term evidence supporting paclitaxel-coated balloons, which are an essential and safe tool for the treatment of patients with PAD who are presenting with increasingly challenging disease and are often at high risk of restenosis,” commented Waksman on the results. “In line with previous clinical data, the Passeo-18 Lux DCB has been shown to be safe at five years when compared to PTA.”

These results confirm the previous analysis of this dataset, published last year, which reported similar mortality at one year irrespective of the treatment with DCB or PTA and clear reduction in the incidence of the composite endpoint of any amputation and target lesion/vessel revascularisation compared to standard PTA. Other recent data have also shown similar mortality rates in patients treated with paclitaxel-coated balloons compared to PTA.

“We are pleased to contribute evidence that helps to address concerns about the safety of paclitaxel-coated technologies and confirm Passeo-18 Lux’s excellent safety record. We are continuing to invest in DCB clinical research including the upcoming BIOPACT RCT, which will further support evidence-based decision making,” said Alexander Uhl, president of vascular intervention at BIOTRONIK.

The BIOPACT RCT clinical trial, which completed enrolment last year, will provide a head-to-head comparison of Passeo-18 Lux and IN.PACT Admiral (Medtronic) DCBs. The primary endpoint will be presented upon completion of 12-month follow-up.

Source VascularNews

Duc Tin CLinic

Tin tức liên quan

Vesteck completes first-in-human use of several Suture-Tight devices

Age is just a number: Individual patient data meta-analysis probes safety of CEA in the elderly

Artificial intelligence can predict risk of complications after endovascular aneurysm repair

Bluegrass Vascular announces Journal of Vascular Surgery paper reporting use of Surfacer system

Vascular access creation: EndoAVF keeps future options open, but is not a replacement for surgical fistulas

SUPPORT CONSULTANT

CUSTOMER REVIEWS

• I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

  I sincerely thank you !. Tel: 0938303275

• Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

  Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

• As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

• The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

• I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search

News

Customer support