CDSCO UID IMP/MD/2019/000225_b139746a26dbcd9ee5cf0f9ac7f51844_fd9ac7afab05583481447a45c72bfcbd
Pericardial Bioprosthesis
Edwards Lifesciences (India) Private Limited,·Device Class Class D·India CDSCO·Brand: Inspiris Resilia Aortic Valve
Registration details
- UID
- IMP/MD/2019/000225_b139746a26dbcd9ee5cf0f9ac7f51844_fd9ac7afab05583481447a45c72bfcbd
- Device class
- Class D
- Brand name
- Inspiris Resilia Aortic Valve
- License holder
- Edwards Lifesciences (India) Private Limited,
- Approving authority
- CDSCO
- Product information
- Pericardial valves are indicated for use in patients suffering from valvular heart disease. Aortic valvular heart disease is a condition involving any of the following: obstruction of the aortic heart valve or stenosis; leakage of the aortic valve, known as regurgitation, incompetence, or insufficiency; and combinations of the two, sometimes referred to as mixed disease or combined lesions. Aortic valvular heart disease may be caused by any number of factors, including congenital abnormalities, infection by various microorganisms, degenerative calcification, and rheumatic heart disease. Pericardial valves are used particularly in those patients for whom long-term anticoagulation is contraindicated or who may be difficult to maintain on anticoagulation therapy. The Magna Ease aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis. The bioprosthesis can be implanted in either the supra-annular or intra-annular position
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About this record
Pericardial Bioprosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000225_b139746a26dbcd9ee5cf0f9ac7f51844_fd9ac7afab05583481447a45c72bfcbd. This device is marketed under the brand name Inspiris Resilia Aortic Valve. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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