BioCardia has announced that the US FDA has approved an investigational device exemption (IDE) for the CardiAMP chronic myocardial ischaemia (CMI) trial to treat patients with refractory angina.
A press release reports that the CardiAMP chronic myocardial ischaemia trial will be a prospective, multicentre, randomised, sham-controlled, patient- and evaluator-blinded pivotal trial to validate the safety and efficacy of CardiAMP investigational cell therapy in the treatment of patients having chronic myocardial ischaemia with refractory angina .
According to the press release, the trial has been approved to enrol up to 343 patients at up to 40 US centres. This trial has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial. This second clinical indication of chronic myocardial ischaemia with refractory angina for the CardiAMP investigational cell therapy follows the company’s FDA-approved pivotal clinical trial of CardiAMP cell therapy in ischaemic heart failure, which is currently enrolling patients.
The press release states that the CardiAMP investigational cell therapy takes a personalised and minimally-invasive approach to the use of a patient’s own cells (autologous cells) in the treatment of cardiovascular disease. The investigational therapy is designed to stimulate the body’s natural healing response.
BioCardia chief executive officer Peter Altman, says: “FDA approval of the CardiAMP chronic myocardial ischaemia trial is another important milestone for the company. It is a step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina. Approval of this second pivotal trial further demonstrates BioCardia’s leadership in the treatment of heart disease.”