Hotline 24/7: 0909384389

Share links:

Medtronic revises IN.PACT post-market study data due to programming error, but conclusions remain the same

Ngày 21/02/2019 06:50 | Lượt xem: 1890

Medtronic has issued the following statement regarding revised clinical study data:

Recently, Medtronic became aware of a programming error in the clinical data reporting isolated to the two- and three-year follow-up periods in our IN.PACT Global post-market study, part of the IN.PACT Admiral clinical programme for the treatment of femoropopliteal artery disease. Preliminary results of this study were first released at the Leipzig Interventional Course (LINC) and Medtronic issued a press release summarising the results on January 22, 2019.

Due to a programming error, mortality data were inadvertently omitted from the summary tables included in the statistical analysis. These deaths were, however, previously included and reported in Medtronic’s database, captured in the appropriate study exit forms and adjudicated by an independent clinical events committee. In addition, the deaths were previously recorded in Medtronic’s complaint system, and MDR/Vigilance reporting has been completed in compliance with the company’s Quality Systems, which are governed by external regulatory requirements.

Immediately upon learning of this error, Medtronic notified the FDA and the study authors. While a component of the recent patient-level meta-analysis will need to be updated, Medtronic has found the revised analysis still supports earlier conclusions that: there was no statistically significant difference in all-cause mortality between the IN.PACT Admiral drug-coated balloon (DCB) and plain balloon angioplasty at five years; there is no correlation between paclitaxel dosing and long-term survival in the studied population; and, there was no difference in mean nominal dose of paclitaxel between overall survival in patients treated with DCB and those who died.

The data update impacts the publication of the IN.PACT Global two-year data in the Journal of the American College of Cardiology: Cardiovascular Interventions(JACC CI), and the IN.PACT paclitaxel safety analysis, which is in print with the Journal of the American College of Cardiology (JACC). Medtronic has confirmed no other IN.PACT studies are affected by this error, and it is important to note this discrepancy is limited to deaths after the one-year time-point.

Respecting the scientific process, the revised analysis is currently moving through the appropriate peer-review with the study authors and JACC so the manuscripts can be appropriately corrected.

Medtronic also notes a related study published on February 12, 2019 in JAMA Cardiology, “Association of Survival With Femoropopliteal Artery Revascularisation With Drug-Coated Devices.” The study authors concluded: “In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.”

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