Table 3.
Representative FDA-approved biomimetic material-based products for human tests since 2012. Data were obtained from http://www.fda.gov/ and https://clinicaltrials.gov/. For earlier examples, please refer to an existing review.1109
| Material | Product name | Company | FDA clearance date |
Product description | Clinical trial |
|---|---|---|---|---|---|
| Collagen | VASCADE Vascular Closure System (VCS) | Cardiva Medical, Inc. | 01/13/2013 | A collagen patch derived from bovine
tissue Potential tissues: vascular, cardiac tissue |
263/275 success |
| Collagen | MACI® /Autologous Cultured Chondrocytes on a Porcine Collagen Membrane | Vericel Corporation | 12/13/2016 | An autologous cellularized
scaffold Potential tissues: cartilage, bone |
49/65 success |
| HA | MONOVISC™ | Anika Therapeutics, Inc. | 02/25/2014 | A single injection gel Potential tissues: knee |
121/181 success |
| HA | GEL-SYN™ | Institut Biochimique S.A. (IBSA) | 20/12/2013 | An artificial gel composed of sodium
hyaluronate Potential tissues: knee, connective tissue |
181/192 success |
| HA | Medtronic CoreValve System | Medtronic CoreValve LLC | 30/3/2015 | An artificial membrane
sheet Potential tissues: vascular, cardiac tissue |
34 /147 success |
| HA | Healon® EndoCoat Ophthalmic Viscosurgical Device | Abbott Medical Optics Inc. | 07/02/2012 | A clear, thick liquid Potential tissues: eyes |
21/199 |
| Bovine tissue | Edwards SAPIEN XT Transcatheter Heart Valve - P130009/S034 | Edwards Lifesciences LLC | 08/09/2015 | A transcatheter aortic
valve Potential tissues: cardiac tissue |
77/96 success |
| Collagen and silicone | Omnigraft Dermal Regeneration Matrix | Integra LifeSciences Corporation | 01/0 7/2016 | Double-layered membrane. The top layer is
silicone and the layer next to the wound is collagen Potential tissues: foot wounds |
79/154 success |
| Sodium carboxymethylcellulose | Radiesse Injectable Implant | Merz North America Inc. | 06/04/2015 | A white, sterile, injectable
gel Potential tissues: hands |
64/85 success |
| PEG | ReSure® Sealant | Ocular Therapeutix, Inc. | 01/08/2014 | A synthetic glycol hydrogel contains a blue
visualization aid Potential tissues: eyes |
302/305 success |
| PEG | Adherus AutoSpray Dural Sealant | HyperBranch Medical Technology, Inc. | 03/30/2015 | A membrane consists of synthetic, absorbable sealant materials | 113/124 success |
| PLLA | Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) System | Abbott Vascular,Inc. | 07/05/2016 | A bioresorbable vascular
scaffold Potential tissues: cardiac tissue |
/ |
| Nitinol | Valiant Thoracic Stent Graft with Captivia Delivery System | Medtronic Vascular | 01/22/2014 | An injectable soft
scaffold Potential tissues: vascular, cardiac tissue |
/ |
| PMMA | Bellafill PMMA Collagen Dermal Filler | Suneva Medical, Inc. | 12/23/2014 | An injectable synthetic
gel Potential tissues: skin |
56/87 success |
| Cyanoacrylate | VenaSeal Closure System | Covidien LLC | 02/20/2015 | A kind of viscous liquid Potential tissues: vascular |
107/108 success |
| PET | Edwards SAPIEN3 Transcatheter Heart Valve | Edwards Lifesciences LLC | 08/18/2016 | A catheter-based artificial aortic heart
valve Potential tissues: cardiac tissue |
/ |
| Combined hydrogel | Raindrop® Near Vision Inlay | ReVision Optics, Inc. | 06/29/2016 | A gel that can be implanted in the
cornea Potential tissues: eyes |
336/344 success |
| Polylactide-co-glycolide acid
co-polymer and polydiaxanone |
Closer Vascular Sealing System (VSS) | Rex Medical, LP | 02/12/2016 | An insertion sheath, dilator and an implant
contained in a delivery system Potential tissues: vascular |
216/220 success |