The drug agency has given the green light to the resumption of clinical trials concerning the artificial heartcarmat.
This ANSM authorization given on May 2, 2017 will allow the biotechnology company Carmat to resume the clinical trial, suspended since October 2016, after the death of the fifth transplant patient. “After an in-depth assessment, the ANSM considers that the company Carmat has provided elements allowing the trial to be resumed under satisfactory safety and risk control conditions”, underlines the health agency. in a press release published on its website. And to add: “The ANSM will be particularly vigilant on patient safety, on the quality of the data provided and on the analysis that will be made of it”. The next five patients included in the clinical trial who will be transplanted by the Carmat heart will be the subject of “an interim global analysis”, further specifies the ANSM.
For its part, the Carmat company claims to be preparing the opening of a new production site, “with more automated processes”, “to strengthen the industrial means necessary for the study”. “The site should be operational at the end of 2017, and would ultimately also meet the production needs for the first phases of the commercial launch of the prosthesis”, points out the company in a press release.
Overcome the lack of available grafts
Presented as a therapeutic alternative for patients suffering from end-stage biventricular heart failure, the Carmat heart prosthesis project aims to compensate for the lack of grafts for tens of thousands of people suffering from irreversible end-stage heart failure.
Since 2013, five patients have been transplanted, all of whom have since died. Their death occurred between one and nine months after the operation, without this being directly linked to the artificial heart, according to AFP.
The fifth patient suffering from severe heart failure and transplanted with a Carmat artificial heart was died in October 2016, a month and a half after the transplant. The National Medicines Safety Agency (ANSM) then decided to suspend all planned settlements, ending a test phase that was supposed to involve 20 patients, until 2018, before a possible commercialization of the Carmat core.
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