Medtronic Statement Regarding IN.PACT Paclitaxel Safety Analysis Correction Letter in The Journal of the American College of Cardiology

High Acceptance of Advanced Healthcare Equipment Promoting Growth of a-Si X-ray Flat Panel Detectors | Fact.MR’s Medtech Analysis

Big data and analytics will drive patient outcomes in a big way, and the coming years will witness a growing emphasis on healthcare service providers in the business of gathering and processing patient health data.

KA Imaging Makes Distribution Deal with Malaysia Based BeyMed

BeyMed is an emerging medical solutions company with a great potential,” said Amol Karnick, President and CEO of KA Imaging. Raises a $3M Series a Round to Scale Up Its Health Tech Platform in the MENA

The UK-based, MENA focused, startup closed $3M in its Series A round of funding led by MEVP with the participation of SOSF, IM capital and returning investors iSME, Cedar Mundi Ventures and IFA capital.

Medtronic announced today that On February 15, 2019, they issued a statement regarding 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 program for the treatment of femoropopliteal artery disease.

In their previous statement, Medtronic said this programming error impacted the IN.PACT Paclitaxel Safety analysis, which recently presented at the Leipzig Interventional Course (LINC) in Leipzig, Germany and published online in the Journal of the American College of Cardiology (JACC).

The revised analysis has been accepted by JACC. Prior to publication of the revised  manuscript, the authors of the study have issued a correction letter addressing key revisions to the dataThe updated  analysis will also be presented by Dr. Peter Schneider at the VIVA Physicians Vascular Leaders Forum (VLF) from March 1-2, 2019 in Washington, D.C.

It is important to reiterate that the initial conclusions from the patient level meta-analysis remain intact:

  • Data found no correlation between paclitaxel dose and long-term survival.
  • Data demonstrated no difference in mean nominal dose of paclitaxel between overall survival in patients treated with DCB and those who died.
  • At five years there was no statistically significant difference in all-cause mortality between the drug-coated balloon (DCB)  and plain balloon angioplasty (PTA) arms.

In addition to the full  cohort, a standard cohort has been included by the authors in the JACC analysis. This was done to correct a baseline imbalance between DCB and PTA by identifying a subgroup of DCB patients who met the inclusion criteria for the  pivotal studies from the IN.PACT clinical program, including IN.PACT SFA, IN.PACT Japan, and IN.PACT China. When only the subjects that mirror the baseline variables in the control PTA group are included, we observe a smaller difference in mortality. When adjusted for these baseline imbalances, all-cause mortality between DCB and PTA was 13.2 percent vs 11 percent (p=0.188).

In line with our  commitment to transparency, we have shared all our patient-level data with FDA  in support of their paclitaxel safety analysis and will plan to do the same to support the upcoming independent VIVA Physicians analysis. Following publication of the revised JACC manuscript, we will also work to correct all impacted materials that live in the public domain.



Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles