Bolder Surgical received FDA approval for CoolSeal™ on October 6, 2020.
The CoolSeal™ Trinity is a 5mm bipolar surgical instrument intended to be utilized for the ligation and division of vessels, soft tissue, and lymphatics during minimally invasive and open procedures. It is a single-use device that has an associated compatible generator which provides radiofrequency energy for vessel seal application. The device can be utilized for arterial structures up to 6mm in size, and venous structures or vascular bundles up to 7mm in diameter.
CoolSeal™ boasts a minimal thermal spread of under 1mm and low temperature “cool” jaws preventing damage to nearby structures. A consistent and strong seal typically requires less than 1.5 seconds. CoolSeal™ Trinity is a Maryland laparoscopic instrument with 360 degree capability, and fine tip, dual action jaws that allow the surgeon to precisely dissect tissue. The device is available in various lengths including 30cm, 37cm, and 44cm.
Additionally, the CoolSeal™ Mini is a similar device that can be used for both adult and pediatric populations. This device is a 3mm instrument that is 20cm in length and can accommodate arterial and vascular structures up to 5mm in size. Similarly to the Trinity, it has a Maryland laparoscopic design with double action jaws.
Biocompatibility of the materials for the CoolSeal™ Trinity and Mini devices was assessed and there were no biocompatibility risks associated with the materials selected. Animal studies confirmed safety of the product.
The FDA determined that CoolSeal™ is substantially equivalent to the following predicate devices: the JustRight™ Generator, JustRight™ Sealer, and the Ligasure™ Maryland Jaw Sealer. This determination was based on literature review, animal studies, in-vivo and ex-vivo vessel burst pressure studies, and in-vivo thermal spread comparisons.
CoolSeal™ Trinity is approved for use in minimally invasive and open general surgery procedures. It accommodates arteries up to 6mm, and veins/vascular bundles up to 7mm in diameter.
CoolSeal™ Mini is approved for use in minimally invasive and open general surgery procedures. It accommodates vascular structures up to 5mm in diameter.
CoolSeal™ Trinity is not effective for tubal sterilization or tubal coagulation and should not be used for such procedures.
CoolSeal™ Mini is not intended to be utilized for ENT procedures.
