Clinical Evidence - VistaCare Medical

Scientific Study - OPEN PMCF Clinical Study

Our post-marketing clinical study has allowed us to provide clinical monitoring of our VistaCare One medical device after obtaining the CE Mark.

The subject of the study was the open-label evaluation of the effects of VistaCare® treatment in routine practice in patients with acute and chronic leg wounds. Initially, it was a question of evaluating the performance and safety of use of the VistaCare device. Secondly, it was necessary to determine the deadline for quality bud and collect reported adverse events.

The study was prospective, open-label, and multicenter; it was carried out within four CHU departments, with different specialties, and was coordinated by Professor Dominique Casanova.

The follow-up of the study, the statistical analyzes, and the final evaluations of the blind images at the end of the study were carried out by organizations and an independent doctor.

Extract from the Open PCMF study results

Point Number 1

31 patients had given their consent to enter the study, 5 patients left the study, including 1 patient who was not included because he did not meet the inclusion/exclusion criteria and 4 exits were premature, which gives us a “Per Protocol” population of 26 patients, who were followed up to obtain granulation tissue and its follow-up up to D+30.

Point Number 2

A large majority of wounds were chronic, almost half of them were more than a year old, also more than 15% were more than 5 years old. 93% of the wounds were judged as difficult, most of them failing with conventional treatments.

Point Number 3

The majority of wounds were ≥ 10m2 and had defects.

What to Take Away from This Study

Key Figures

3.9 days

Time to obtain optimum granulation tissue to decide of a covering gesture (graft, dressing, flap)

~ 3 to 4 hours of daily interruption

Versus ATEC study: Algosteril®: 19.98 days and TPN: 20.56 days

24 hours

Drastic reduction of pain

85%

Improvement after a 7-day treatment only under VistaCare® including 14 patients at +1 year of treatment.

Improvement at a distance (23 patients) from the treatment (at 30 days). For the other three: 2 failures not attributed to VistaCare and 1 static state.

**Transplant performed and 1 patient improving at the end of VistaCare® treatment.

Real Life Data - Clinical Cases

The effectiveness of VistaCare in everyday practice

The collection of clinical cases allows the evaluation of the therapeutic effects of one or more treatments "in real life", whether this result is positive or even negative. This is why we have collected several clinical cases to monitor the effectiveness of WEC therapy in the treatment of complex wounds.

All the clinical cases collected reinforce the results of the clinical study which reports the obtaining of quality granulation tissue in 10 days, more or less 4 days.

We will also note 88.5% improvement in wounds after just 7 days of treatment with VistaCare.

Different Acute clinical cases

VistaCare treats both so-called acute wounds and chronic wounds. Below, we also present various examples of clinical cases treated with our device.

Scientific Documentation

Abstract of the VistaCare Medical OPEN PMCF Clinical Study:

Detailed results of the OPEN PMCF clinical study conducted after obtaining CE marking for our VistaCare One device.

Scientific Posters:

These scientific posters were created by clinicians who use our VistaCare One device. They illustrate and confirm the results of our clinical study in real-life settings.