Gestern gab es für XTNT eine geniale Meldung seitens der FDA.
XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration
XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration
MENLO PARK, Calif., June 4 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced that the Company received conditional approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) authorizing it to begin its pivotal clinical program, composed of two pivotal trials called CUSTOM IV and CUSTOM IV Angio to support the approval in the United States of its Custom NX(R) Drug Eluting Stent (DES) System. The conditional approval requires the Company to address some technical issues about which the FDA has questions prior to granting full approval.
'This conditional approval further demonstrates the progress made in the development of a truly revolutionary drug eluting stent system,' said Greg Casciaro, President and Chief Executive Officer of XTENT, Inc. 'I want to recognize each and every XTENT employee, and especially Dr. Philippe Marco, our Vice President of Quality Assurance, Clinical and Regulatory Affairs, for their dedication and efforts in introducing a new drug and coating formulation along with a new delivery platform through this regulatory process. We also must credit the active participation and support of our BA-9/PLA licensor, Biosensors.'
XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration
XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration
MENLO PARK, Calif., June 4 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced that the Company received conditional approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) authorizing it to begin its pivotal clinical program, composed of two pivotal trials called CUSTOM IV and CUSTOM IV Angio to support the approval in the United States of its Custom NX(R) Drug Eluting Stent (DES) System. The conditional approval requires the Company to address some technical issues about which the FDA has questions prior to granting full approval.
'This conditional approval further demonstrates the progress made in the development of a truly revolutionary drug eluting stent system,' said Greg Casciaro, President and Chief Executive Officer of XTENT, Inc. 'I want to recognize each and every XTENT employee, and especially Dr. Philippe Marco, our Vice President of Quality Assurance, Clinical and Regulatory Affairs, for their dedication and efforts in introducing a new drug and coating formulation along with a new delivery platform through this regulatory process. We also must credit the active participation and support of our BA-9/PLA licensor, Biosensors.'
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