Import Nod on Hold Over False Positives, Tissue Detection: CDSCO Panel Seeks More Data on Medtronic's PTeye Device
New Delhi: Responding to India Medtronic Private Limited's proposal seeking permission to import and market the medical device "PT Eye Parathyroid Detection System," manufactured by Medtronic Xomed Inc., USA, the Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organization (CDSCO), has sought additional data before taking a final decision.
The committee specifically asked the firm to provide:
- Detailed data on false positive results reported during the clinical studies conducted with the device.
- Clarification, supported by documented evidence, on whether the device is capable of detecting de-vascularized parathyroid tissue.
This came after the firm presented their proposal for a grant of permission to import and market the medical device viz. the PT eye Parathyroid Detection System, manufactured by M/s Medtronic Xomed Inc., USA.
Parathyroid tissue can be difficult to distinguish visually from surrounding tissue during surgery. The PTeye parathyroid detection system uses a laser probe to elicit a fluorescent response from suspected parathyroid tissue.
The PTeye parathyroid detection system can be used in thyroidectomy and parathyroidectomy procedures.
The PTeye system is an adjunctive tool intended to aid in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon.
The committee at the recent SEC meeting noted that the said device has been approved for marketing in the country of origin for more than two years and also marketed in other major countries.
The firm has submitted post-marketing surveillance data and clinical study data to demonstrate the safety and performance of the device.
After detailed deliberation, the committee opined that the firm shall submit the following data for further deliberation with the committee along with the presence of at least two parathyroid surgeons, an endocrine surgeon, and a biomedical engineer for taking further necessary action:
1. Details on false positive results reported in the clinical studies conducted.
2. Clarification with documented evidence of whether the device will detect devascularized parathyroid tissue.
