With the progress of science and technology, medical device products are changing with each passing day. The United States can be called the "fertile ground" of medical device innovation, and the progress of its medical device products has a weathervane role. In the first quarter of this year, what new medical device products were approved for sale in the United States? Let's find out.

TRILURON™

Pre-filled disposable syringes with sodium hyaluronate glory

Hyaluronic acid is a substance in the human body that is found in places such as joint tissue. The body's own hyaluronic acid acts as a "lubricant" and "shock absorber" in the joints, which can ensure the normal work of the joints. Patients with osteoarthritis do not produce enough hyaluronic acid, and the quality of hyaluronic acid and its cushioning and lubrication ability also change to some extent. Often, physical therapy and simple pain medications such as nonsteroidal anti-inflammatory drugs such as acetaminophen doot respond to these patients.

TRILURON™ can be used to treat patients with osteoarthritis of the knee and can be injected directly into the patient's knee by a doctor to relieve pain associated with osteoarthritis for up to 6 months with a 2 ml injection 3 times a week. It is important to note that the device is not suitable for people who are allergic to sodium hyaluronate preparations, and those who have skin diseases around the injection site.

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OPTIMIZER Intelligent system

The OPTIMIZER intelligent system includes an implantable pulse generator (IPG), a charging system and a programmer. IPG can monitor the activity of the heart and deliver non-excitatory electrical signals to the right ventricle of the heart in patients with chronic heart failure (myocardial contractility regulation therapy); The charging system is used to charge the IPG and the programmer so that the medical staff can set up the control device.

The OPTIMIZER smart system implants IPG under the skin in the upper left or right area of the patient's chest and connects to electrodes connected to the heart. After implantation, the device is tested and programmed according to the patient's individual requirements. The smart system is intended for patients 18 years of age and older who have moderate to severe heart failure symptoms and have not responded to medical treatment.

The OPTIMIZER Smart system is not intended for patients with: permanent or long-term persistent abnormal heart rhythm (atrial fibrillation); Using an artificial tricuspid valve; Unable to obtain the vascular access needed to implant the electrodes.

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MitraClip mitral valve repair System

The MitraClip mitral valve repair system contains a permanent implant that looks and functions like a clip. The "clamp" is used to grab the two lobules of the mitral valve in the heart and clip them together to reduce blood return (called mitral regurgitation or MR).

During surgery, the doctor uses a tubular device (delivery catheter) to insert the MitraClip through the femoral vein of the thigh and guide it to the left side of the heart. The mitral valve is then left in place by grabbing the two lobules of it and positioning the "clamp." Remove the catheter after placing the "clamp".

MitraClip is designed to treat certain patients with moderate to severe or severe secondary MR. The device should not be used in patients who: cannot tolerate anticoagulants and antiplatelet agents during and after surgery; Patients with active inflammation of the heart (endocarditis); Rheumatic mitral valve disease; Blood clots in the heart or veins leading to the heart.

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VENOVO venous stent

The VENOVO venous stent system is used to treat narrow veins (iliofemoral veins) from the upper pelvic region to the groin region. The VENOVO venous stent system has two components: a stent made of Nitinol tubes and an in-line stent delivery catheter system.

The doctor inserts a thin flexible tube (delivery system) and the stent fits inside its tip into the narrow section of the iliofemoral vein. The doctor rotates the thumb wheel on the delivery system to expose the stent, which automatically expands. By keeping the iliofemoral vein wall open, the stent increases blood flow to the legs. The stent is permanently implanted in the vein and can serve as a support for the newly opened part of the blood vessel.

The VENOVO venous stent system is not intended for patients who have lesions that affect the crossing or complete expansion of the angioplasty balloon and the proper placement of the stent or stent delivery system; Patients who are unable to receive anticoagulant and antiplatelet drugs, such as aspirin or coumarin; Patients with known allergies to nickel, titanium, or tantalum.

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VENTANA PD-L1 test kit

The VENTANA PD-L1 test kit is used to test samples from patients with triple-negative breast cancer. This test can help doctors determine if Atezolizumab is the best treatment option for patients. Atezolizumab is a drug that blocks PD-L1 and is used in combination with paclitaxel protein to treat triple-negative breast cancer.

Laboratory testers can process the sections using the VENTANA PD-L1 (SP142) Assay. If the slice has PD-L1, it will be dyed dark brown. Patients with a positive test result after this test may benefit from the Atezolizumab drug.