Toulouse, 4th June 2015 – VEXIM (FR0011072602 – ALVXM / Eligible PEA-PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announced the initiation of a new clinical study intended to support the Company’s application for 510(k) regulatory clearance to market SpineJack® in the U.S.
Study will assess the safety and efficacy of SpineJack® compared with balloon kyphoplasty in 160 patients in Europe
Based on discussions with the U.S. Food and Drug Administration, Vexim will supplement its regulatory submission for the use of SpineJack® in the U.S. with a prospective European multicentric randomized study that compares the safety and efficacy at one year follow-up of the New Generation SpineJack® device with Medtronic’s balloon in 160 patients suffering from vertebral compression fractures due to osteoporosis.
Vincent Gardès, CEO of VEXIM, said: “The initiation of this clinical study is a significant milestone for Vexim. This is another important step towards the intended commercialization of our Spinejack® technology in the United States. We continue to expect that we will submit a 510(k) application in 2017.”
This comparative study recently received approval from Ethical Committees and Health authorities in each country and is being conducted in 8 European centers. Additional patients are expected to be enrolled over the coming weeks in France, Switzerland, Germany, and Spain.
The study will document and compare improvements in back pain, back function, narcotic medication usage, height restoration and quality of life, as well as safety profiles, in patients with osteoporotic vertebral compression fractures undergoing the SpineJack procedure and Medtronic’s balloon kyphoplasty. Patients will be monitored post-implantation and followed up with through 12 months post-surgery.
All radiographic images will be assessed by an independent imaging core laboratory. The assessment of the device condition and performance will be performed by a blinded 2-reader system, with a third reviewer as adjudicator for readings that differ between the two independent reviewers. The reviewers are board-certified, practicing specialist radiologists with no financial interest in the company. The reviewers are blinded to the patient visit interval, treatment group and other reader(s) result.
This results of this study are expected to be included within a 510(k) submission in 2017.
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Study will assess the safety and efficacy of SpineJack® compared with balloon kyphoplasty in 160 patients in Europe
Based on discussions with the U.S. Food and Drug Administration, Vexim will supplement its regulatory submission for the use of SpineJack® in the U.S. with a prospective European multicentric randomized study that compares the safety and efficacy at one year follow-up of the New Generation SpineJack® device with Medtronic’s balloon in 160 patients suffering from vertebral compression fractures due to osteoporosis.
Vincent Gardès, CEO of VEXIM, said: “The initiation of this clinical study is a significant milestone for Vexim. This is another important step towards the intended commercialization of our Spinejack® technology in the United States. We continue to expect that we will submit a 510(k) application in 2017.”
This comparative study recently received approval from Ethical Committees and Health authorities in each country and is being conducted in 8 European centers. Additional patients are expected to be enrolled over the coming weeks in France, Switzerland, Germany, and Spain.
The study will document and compare improvements in back pain, back function, narcotic medication usage, height restoration and quality of life, as well as safety profiles, in patients with osteoporotic vertebral compression fractures undergoing the SpineJack procedure and Medtronic’s balloon kyphoplasty. Patients will be monitored post-implantation and followed up with through 12 months post-surgery.
All radiographic images will be assessed by an independent imaging core laboratory. The assessment of the device condition and performance will be performed by a blinded 2-reader system, with a third reviewer as adjudicator for readings that differ between the two independent reviewers. The reviewers are board-certified, practicing specialist radiologists with no financial interest in the company. The reviewers are blinded to the patient visit interval, treatment group and other reader(s) result.
This results of this study are expected to be included within a 510(k) submission in 2017.
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