TisFree ®️ Ultrasonic Soft Tissue Cutting & Hemostasis Device was recently approved for registration by the Brazilian National Health Surveillance Agency

Recently, bluesail Surgical's self-developed and designed TisFree ®️ Ultrasonic Soft Tissue Cutting & Hemostasis Device was recently approved for registration by the Brazilian National Health Surveillance Agency (Brazil ANVISA).

The Brazilian National Health Surveillance Agency (ANVISA) is responsible for the pre-market approval and post-market surveillance of pharmaceuticals, food, cosmetics, medical devices, in vitro diagnostics and other products in Brazil. In Brazil, the production, importation, storage, transportation, and sale of health-related products are all subject to ANVISA's qualification certificates to protect the safety and effectiveness of health-related products on the market.

Brazil is a large economic country in South America, its basic medical devices are imported from overseas, so Brazil has its own independent and complete medical device registration and certification system, that is, ANVISA certification.

The rigor of ANVISA certification is no less than the FDA certification, the review time is usually 6 months - 2 years, in the premise of submitting the complete information, the long time cycle is also a serious test. The long time period is also a severe test under the premise of submitting complete information. This certification means that the company's products will formally enter the Brazilian market, for the company to further develop the South American market has laid a solid foundation. In the future, bluesail Surgical will continue to plow into the South American market and provide local patients with high-quality and affordable surgical medical solutions.

1. Optimized design Efficient output

Improved piezoelectric coupling technology to further optimize broadband high power output, effectively reduce the integrated impedance of the transducer and greatly improve the output efficiency.

1. Intelligent Algorithm Persistent Output

Effectively improves the mechanical energy conversion rate and precisely guarantees the consistency of the output amplitude of the cutter head, which ensures durable, efficient and stable cutting efficiency and safe hemostasis in minimally invasive surgery.

1. Excellence in Performancer

Experts from the clinical trial team analyzed detailed data from various aspects such as overall satisfaction rate of intraoperative soft tissue, effect of vascular closure, and stratified analysis of open surgery and lumpectomy respectively, and showed that there was no difference in overall satisfaction with the effect of soft tissue separation and cutting and the effect of hemostasis; there was no difference in intraoperative closure of blood vessels, bleeding volume, drainage volume, and performance of instrumentation; and there was no difference in postoperative vital signs, adverse events, and other indicators of stability. .

New 5mm dissector

1. New technology and upgraded appearance

The new design is more exquisite in appearance and more ergonomic in shape, which greatly reduces the fatigue of the operator during the operation.

1. 5mm blood vessels sealing- Safe and convenient

TisFree uses real-time jaw pressure feedback and energy regulation for precise algorithmic control when dealing with various types of vascular tissues, allowing the tip to strike a balance between cutting as well as coagulation, resulting in superior hemostasis and vascular closure, which can effectively close blood vessels with a diameter of 5mm and below. In gastrointestinal, urological, thoracic, hepatobiliary, gynecological and other surgical procedures, the ability of 5mm vascular closure, when the operator to deal with vascular plexus, deep space, dealing with blood vessels can be more comfortable, convenient, reduce bleeding, reduce the use of other auxiliary instruments.

Bluesail Surgical

Looking into the future, by virtue of the clinical value-driven product pipeline innovation, as well as lean manufacturing and innovative R & D simultaneously, the domestic and overseas markets in a two-pronged approach to the "high-flying" concept, bluesail Surgical is bound to create ripples in the international market!