XTENT, Inc. announced that the company received conditional approval from the US 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 US of its Custom NX 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.
This is a significant milestone for a technology that was designed to treat complex patient population that presents with multi-vessel coronary artery disease and/or long lesions, said Martin B. Leon, M.D., Associate Director of the Center for Interventional Vascular Therapy, New York-Presbyterian Hospital/Columbia University Medical Center. It will be a missed opportunity if this technology does not carry forward in development quickly as it not only potentially fills the unmet clinical needs we have, but it may also address the increasing cost pressures faced by the global healthcare system by potentially reducing the total procedural cost for coronary stenting.
This is a bitter sweet announcement because of the timing, added Casciaro. Although the company’s Board of Directors has approved a plan of complete liquidation and dissolution, we will continue to consider any reasonable alternative strategic proposals presented to us prior to the upcoming shareholder meeting.