The Mumbai-based Edwards Life Sciences Pvt Ltd has received the green signal from the Union health ministry for importing and marketing of medical device SAPIEN xt-Transcatheter Heart Valve with the Novaflex+ Transfemoral Kit without any clinical trial on Indian population.

According to sources, the Apex Committee of the Union health ministry headed by health secretary in its meeting held recently deliberated on the issue and accorded the green signal to the Mumbai-based firm.

Earlier, the firm had applied for the import registration and marketing of SAPIEN xt-Transcatheter Heart Valve with the Novaflex+ Transfemoral Kit without local trial.  As similar product is not yet approved, the application of the firm was referred to MDAC Cardiovascular.

Sources said that the application of the firm was discussed in the MDAC Cardiovascular meeting held on 21.10.2014, wherein the Committee noted that the device has already been approved in various countries i.e., USA, Japan, Canada, EU, etc. The data submitted shows that the device is safe and effective for its intended use. However, the Committee recommended to prove the safety and effectiveness of the device in the Indian population and hence a clinical trial study would be required to be conducted. The firm is required to submit the clinical trial protocol to DCGI for consideration and same would be placed before the Technical Committee for further review and taking further necessary action in the matter.

The firm Edwards Life Sciences then made a representation with additional information and reports to the DGHS which was forwarded to the DCGI for further consideration in the Technical Committee.

The representation of the firm was deliberated by the Technical Committee along with the recommendations of MDAC and the Committee observed that this Trans Catheter Heart Valve System is approved in major countries and such systems are also being used in India. The Committee reviewed the recommendation of the MDAC along with the representation of the applicant and specifically mentioned that “the cardiologists and the cardiac surgeons are present today in the Committee and in their opinion this device system can be approved for import & marketing without the requirement of clinical trial in Indian population, subject to the condition that it shall be used in cases which are not fit for surgery and in morbid condition on the advice of cardiac surgeon and cardiologists”.

The Committee also opined that there is unmet need for such devices. However, the Technical Committee recommended that systematic PMS data of first 100 patients shall be generated and submitted to CDSCO along with the periodic safety update review.

The Apex Committee in its meeting on December 24, 2014 deliberated upon the proposal and concurred with the recommendations of the Technical Committee.