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A post-market, prospective, multi-center | 合法醫療器材資訊網

A post-market, prospective, multi-center

由MMJvanRooijen著作·2018·被引用8次—Despitereducingherniarecurrencerates,theuseofsyntheticmeshhasbeenassociatedwithcomplicationsinapproximately17%ofpatients.

 A post-market, prospective, multi-center

Objectives

The objective of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring VHWG Grade 3 midline incisional hernia repair. Among others, Surgical Site Occurrence (SSO), hernia recurrence, pain, infection, reoperation and adverse events will be collected for subjects with a VHWG Grade 3 hernia meeting the study inclusion and exclusion criteria.

Design

The study has been designed as a post-market, prospective, single arm, multi-center, open-label study to collect data on performance and safety of Phasix™ Mesh in subjects with a VHWG Grade 3 midline hernia. This study will be conducted in 15 hospitals across Europe, which will each be allowed to include a maximum of 15 patients.

Participants

Subjects with a VHWG Grade 3 incisional hernia scheduled for hernia repair are eligible for this study and will be asked f...

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Prospective | 合法醫療器材資訊網
由 JS Roth 著作 · 2020 · 被引用 3 次 — Long-term outcomes following ventral hernia repair with P4HB mesh ... (Phasix™​) mesh for hernia repair in cohort at risk for complications: ... Read More
Outcomes of a new slowly resorbable biosynthetic mesh ... | 合法醫療器材資訊網
由 MMJ van Rooijen 著作 · 2020 · 被引用 5 次 — Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. ... These results on infection and complications rates are valuable for the ... Read More
When the Mesh Goes Away | 合法醫療器材資訊網
由 CA Messa IV 著作 · 2019 · 被引用 14 次 — 14–16 Yet, due to the inherent permanence, long-term complications are ... 27 Poly-4-hydroxybutyrate (P4HB) (Phasix Mesh; C.R. Bard Inc., ... Read More
Clinical outcomes and quality of life associated with the use of ... | 合法醫療器材資訊網
由 C Rognoni 著作 · 2020 · 被引用 9 次 — The main complications were: 1.3% infected mesh removal, 4.0% ... To date, Phasix meshes have proven to be suitable prostheses in ... Read More
Phasix™ Mesh | 合法醫療器材資訊網
Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction,​ ... Read More
Phasix™ ST Mesh | 合法醫療器材資訊網
Phasix™ ST Mesh is a bioresorbable scaffold featuring Sepra® Technology. ... Possible complications in hiatal hernia repair may include esophageal erosion ... Read More
Fully Resorbable Scaffold for Hernia Repair | 合法醫療器材資訊網
In some instances, complications may occur, requiring removal ... Phasix™ Mesh provides an open monofilament mesh for rapid tissue incorporation that has. Read More
What Hernia Mesh Has Been Recalled? | 合法醫療器材資訊網
2021年3月8日 — Many brands of hernia mesh has been recalled due to serious complications, including reactions from biologically incompatible material. Read More
Hernia Mesh Recall | 合法醫療器材資訊網
2018年11月27日 — Hernia mesh manufacturers have recalled more than 211000 units from 2005 to 2019. Complications include mesh failure, punctured organs ... Read More
A post-market, prospective, multi-center | 合法醫療器材資訊網
由 MMJ van Rooijen 著作 · 2018 · 被引用 8 次 — Despite reducing hernia recurrence rates, the use of synthetic mesh has been associated with complications in approximately 17% of patients. Read More
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