Watchman (heart implant)

2023: Watchman FLX Pro Implant Release

On September 6, 2023, Boston Scientific announced the Watchman FLX Pro heart implant, the use of which helps prevent stroke.

Watchman FLX Pro is a left atrial eye occluder. This is a special blood clot trap mesh, the use of which is indicated for patients with atrial fibrillation. arrhythmia The main danger of this ailment is due to the formation of blood clots in the ear of the left atrium, which spread through the body and overlap the lumen of the arteries of the brain. brain As a result, a stroke can occur.

Boston Scientific releases heart implant that prevents strokes

In order to prevent formations blood clots in atrial fibrillation, patients are prescribed oral anticoagulant therapy. However, this method is not always effective. Therefore, in some cases, occluders are used that prevent blood clots from entering the systemic bloodstream.

The Watchman FLX Pro implant has received a special polymer coating that provides faster and controlled tissue healing around the device. In addition, visualization markers have been added to improve placement. Compared to previous generation products, the choice of available sizes is expanded, which allows you to meet the needs of more patients with different anatomical features. The solution retains key characteristics of the previous version, including a fully rounded design that allows surgeons to safely enter and maneuver inside the left atrial ear.

Preclinical studies showed an 86% reduction in inflammation three days after the implantation procedure due to the polymer coating. The product provides a 70% reduction in the number of blood clots within 14 days. The product has received approval from the U.S. Food and Drug Administration (FDA).^[1]

2021: Results of a 12-month test of the device

In early April 2021, Boston Scientific presented the results of a 12-month trial of the new generation Watchman device for left atrial ear occlusion (LAAC).

Endovascular occlusion of the left atrial ear - surgery performed in atrial fibrillation (AF), the most common heart rhythm disorder. AF is fraught with a high risk of thromboembolism, with 90% of strokes due to thromboembolism being caused by left atrial ear thrombosis. One way to prevent thromboembolic complications of AF is by surgical methods to isolate the eye from the bloodstream, among which endovascular interventions are considered the least traumatic.

Watchman heart implant to prevent stroke

The results of the Pinnacle FLX study were published in the medical journal Circulation and prove the safety and efficacy of Watchman for stroke prevention in patients with non-valvular atrial fibrillation. In a study of 400 patients, the Watchman FLX device was seen as an alternative to oral anticoagulant therapy, which is often used to reduce risk but risks bleeding. The study reached its primary safety endpoint within seven days of the procedure. The incidence of endovascular-related adverse events was 0.5%.

In addition, the study achieved its primary efficacy endpoint as the data demonstrated 100% efficacy of LAAC 12 months after the procedure. The implantation success rate was 98.8% and no patients experienced perioperative death, device embolization, or pericardial effusion requiring cardiac surgery. In addition, 96.2% of patients were able to discontinue oral anticoagulants after a 45-day follow-up.^[2]

2020: Watchman FLX announcement - heart implant to prevent stroke

In late July 2020, Boston Scientific introduced a heart implant to prevent stroke. Watchman FLX left atrial eye occluder reduces the risk of stroke without increasing the risk of bleeding, unlike anticoagulants, drugs designed to suppress coagulation and prevent the formation of thrombolytic changes. Implantation of the device is indicated in patients with atrial fibrillation without valvular damage.

Boston Scientific says the Watchman FLX device is easy to implant as well as reattach and move. The new frame design provides optimal grip on the fabric and long life. According to the developers, the rounded design of the Watchman FLX gives doctors the ability to safely conduct the device in the ear of the left atrium and maneuver in it. Cardiac surgeons have a wide range of sizes available that allows them to take into account the anatomical characteristics of the patient.

Heart implant to prevent stroke

The efficacy of Watchman FLX as an alternative to long-term oral anticoagulants was evaluated in the one-year pivotal PINNACLE FLX trial. The prospective, non-randomized PINNACLE FLX trial included 400 patients USA with non-valvular atrial fibrillation. All of these patients had indications for anticoagulant therapy to reduce stroke risk, but sought a non-pharmaceutical alternative due to contraindications.

The primary safety and efficacy endpoints show a low incidence of procedure-related adverse events (0.5% at 7 days post-treatment) and a high degree of effective occlusion (100% at 12 months post-treatment).

The previous generation Watchman implant was released in 2015, and the results of a long-term study demonstrated its effectiveness. Boston Scientific announced that Watchman FLX will begin to gradually enter the US market from July 2020.^[3]

2017: Practical Use

In May 2017, medical device manufacturer Boston Scientific spoke about the successful use of its heart implant Watchman, which reduces the risk of stroke.

Watchman is a device that looks like a miniature umbrella or net. The device is made of polyethylene terephthalate and nitinol, the size of the umbrella is 21-33 mm (the diameter of the device is individually selected during the operation). 

Watchman

The manufacturer says Watchman is an effective minimally invasive treatment for atrial fibrillation. The device is placed in the heart and prevents microthrombs from entering the blood channel, which supplies blood to the brain. Watchman replaces prolonged use of blood-thinning anticoagulant drugs.

Watchman is installed as follows: a conductor is passed through the artery of the leg with a mesh at the end, which, under the control of ultrasound and X-ray, spreads inside the heart. Given that certain stages of the procedure are painful, either general anesthesia or deep sedation is usually applied. The implant blocks the appendage of the left atrium, which affects the occurrence of blood clots in the human body.

By May 2017, Watchman is approved by the Food and Drug Administration (FDA). The device is already used in operations in some clinics, including Israel.

As of May 2017, there are more than 6 million people in the United States suffering from atrial fibrillation, which increases the risk of developing heart failure and heart attack.

According to the Boston Scientific, studies conducted showed that the risk of stroke after installing Watchman decreased significantly. In addition, there was no need for anticoagulant drug therapy.^[4]

Notes