The first silver/platinum orthopedic screw cleared with the labeling of “anti-microbial”
Silver-Platinum screws have just been cleared in Europe with the CE Mark.
Here are some talking points that I put together.
- Indication For Use: OrthoFuzIon Bone Screws are indicated for open reduction and internal fixation (ORIF) fracture surgeries and are plated to inhibit microbial colonization and reduce implant related infection in revision surgery due to implant infection or primary surgery in patients who are at-risk of implant infections.
- Device Description: The Silver Bullet Therapeutics OrthoFuzIon Bone Screw System is a bone screw system composed of single use devices for the fixation, correction and/or stabilization of bones. The OrthoFuzIon Bone Screw System includes two screw types: a) A standard medical grade titanium alloy (ASTM F-136) cannulated screw that is plated with both platinum and silver to inhibit the growth of microorganisms on the screw. b) A standard medical grade titanium alloy (ASTM F-136) solid screw that is plated with both platinum and silver to inhibit the growth of microorganisms on the screw.
- The first regulatory cleared product in the world with a “reduction of infection” claim for an orthopedic implant for both primary surgery in high-risk patients as well as revision surgery patients
- Tiger Woods accident is a good example of where this product is certainly indicated as well as patients like Alex Smith who has undergone 17 surgeries from infections.
- Silver Bullet Therapeutics demonstrated effectiveness of their coating against the Top 6 CDC bacterial super bugs at an independent laboratory nearly 5 years ago. https://www.businesswire.com/news/home/20161103006418/en/Silver-Bullet-Therapeutics-Reports-Results-of-OrthoFuzIon%C2%AE-Antimicrobial-Bone-Screw-Testing-Against-the-Top-Six-CDC-Antibiotic-Resistant-%E2%80%9CSuperbugs%E2%80%9D1
- The OrthoFuzIon AntiBacterIon coating is durable and resistant to handling and manipulation damage unlike other coatings.
- Although Staphylococcus is the most common bacteria in orthopedic implant infections, rising worldwide antibiotic resistance indicates that orthopedic patients, especially trauma, must be exposed to more aggressive asceptic methods and technologies like the Silver Bullet AnitiBacterIon coating. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5775060/
- In conversations with the company, the costs added to typical titanium screws are minimal when you consider the ASP’s and the potential dominance that this will have in the EU marketplace. In fact, margins probably would not suffer at all by pricing the product at parity to the market.
- Read the Instructions for Use (IFU) –
For more information go here.
President & CEO
Silver Bullet Therapeutics, Inc. Suite D2362
San Jose, CA 95131
Tel: (408) 436-7500
Cell: (408) 891-6361