Medtronic Launches Penditure™ Left Atrial Appendage Exclusion System in the U.S.

Nov 29, 2023 00:02 CST Updated 00:02

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source of the article:Heart NotCome;Editor:Liu Xinyi

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On November 27, 2023, Medtronic (NYSE: MDT) announced the launch of the Penditure™ Left Atrial Appendage Exclusion System in the United States.

Penditure™ Left Atrial Appendage (LAA) Exclusion System

# About Penditure™ Left Atrial Appendage Occlusion System

The Penditure™ system is an innovative implantable clip that uses physical means to compress and occlude the left atrial appendage, assisting in the management of the left atrial appendage (LAAM) during cardiac surgery. The left atrial appendage is a small pouch-like structure extending from the left atrium, shaped similarly to an ear. The inner wall of the left atrial appendage contains well-developed pectinate muscles and trabeculae, but the inner wall is not smooth. The serrated notches at the edge of the appendage present a lobulated appearance, which can create vortices in rapidly flowing blood, slowing down the blood flow, easily leading to blood stasis and promoting thrombus formation.

Clinical studies show that in patients with atrial fibrillation (AF), over 90% of thrombus formation is associated with the left atrial appendage. It is not an exaggeration to call the left atrial appendage the "thrombus base" for AF patients. In healthy individuals with normal sinus rhythm, the left atrial appendage has rhythmic contractile ability, and the blood flow inside the auricle cavity moves periodically, making thrombus formation rare. However, during atrial fibrillation, the auricle exhibits slight tremors, leading to decreased contractile function, significantly slower blood flow within the left atrial appendage, continuous stagnation of blood flow, and eventually the formation of lump-like thrombi.

When a thrombus formed in the left atrial appendage detaches, it can travel from the left atrial appendage to the left ventricle, then to the arterial system, and subsequently to organs throughout the body. If the embolus blocks an artery within the skull and impedes blood flow, it can cause an ischemic stroke, commonly referred to as "stroke."

Given the significant role of the left atrial appendage in thrombus formation in patients with atrial fibrillation, transcatheter left atrial appendage closure has received widespread clinical attention in recent years.

The American College of Cardiology (ACC), the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS) all recommend that patients with atrial fibrillation should undergo left atrial appendage occlusion before concurrent cardiac surgery. This is becausePatients with atrial fibrillation face a higher risk of stroke, approximately five times that of patients without atrial fibrillation, and most stroke-causing blood clots originate from the left atrial appendage.。

Medtronic's clip is designed in a curved shape to better match the anatomy of the atrium. Meanwhile, this clip has no fabric, enabling atraumatic closure and reducing patient inflammation. This clip is currentlyThe only left atrial appendage clip that can be retrieved and redeployed during surgery, doctors can better adapt to changes during the surgical process. Dr. Gorav Ailawadi and Dr. Basel Ramlawi used this device to perform the first clinical surgeries at the Frankel Cardiovascular Center of the University of Michigan and the Lankenau Heart Institute, respectively.

Gorav Ailawadi, MD (left) and Basel Ramlawi, MD (right)

This clip belongs to Medtronic this year.Penditure Device Technology Acquired from Syntheon in August, the clip is inReceived FDA 510(k) clearance in the same month, with limited availability in the United States. This acquisition expanded the company's Cardiac Surgery product portfolio, adding the Left Atrial Appendage (LAA) management segment.

After this clip is launched under Medtronic, the recruitment for the related trial (PendITure™ Post-Market Study) will begin in early 2024, aiming to further evaluate the clinical effectiveness of the Penditure™ Left Atrial Appendage Occlusion System. The trial will be a multi-center, single-arm, non-randomized, interventional post-market study, enrolling approximately 150 patients across 25 sites in the United States.

# About Left Atrial Appendage Occlusion

Generally speaking, the surgical principle of left atrial appendage occlusion is to use a minimally invasive method to compress the occluder into a thin tube, which is then delivered through blood vessels to the left atrial appendage. After releasing the occluder, it blocks the opening of the left atrial appendage to prevent thrombus detachment within the left atrial appendage.

The doctor will establish a channel by puncturing the patient's femoral vein, with a wound size of about 1 cm. The patient can get out of bed and move around 6-12 hours after the surgery, and the wound generally heals in 1-2 days. The surgery can be completed under general or local anesthesia, with intraoperative assessment conducted via X-ray and ultrasound.

# Doctor's Evaluation + Executive's Evaluation

Dr. Gorav Ailawadi said, "This clip is an innovation in this field, allowing doctors to have better control over the surgical process... It has a 'regret' function, enhancing the safety of the surgery."

Dr. Basel Ramlawi said, "This device can effectively occlude the left atrial appendage, and the surgical outcomes are excellent with good echocardiographic results for the patients. ... Doctors can adjust the position of the clip as needed to ensure its optimal placement."

Karim Bandali, MD, Vice President of Heart Surgery Business in Medtronic's Cardiovascular Portfolio, stated: "The strategic launch of the Penditure™ Left Atrial Appendage Occlusion System aims to assist cardiac surgeons... We have introduced a differentiated solution for left atrial appendage management."

Karim Bandali

# About Syntheon

Syntheon, founded in the United States in 1999, is currently privately held and is a well-known medical device incubator dedicated to the development of medical equipment. The company now holds over 200 patents, with sales exceeding $60 billion, has improved medical care for 52 million patients, and collaborates with several renowned companies (Johnson & Johnson, Boston Scientific, etc.).

# About Medtronic

Medtronic is a global leading medical technology company, founded in 1949, with its headquarters located in Minneapolis, Minnesota, USA. The company mainly focuses on providing lifelong treatment, diagnosis, and monitoring solutions for patients with chronic diseases such as cardiovascular disease, neurology, diabetes, and spinal disorders.

On November 21, 2023, Medtronic announced its financial results for the second quarter of fiscal year 2024 (FY24), ended October 27, 2023. The earnings report showed that global revenue for the second quarter was $7.984 billion, representing a year-over-year increase of 5.3%, with organic growth of 5.0%. The company's core business demonstrated strong growth, with multiple regions and various business segments achieving increases. Revenue from the Cardiovascular portfolio reached $2.923 billion, up 5.9% year-over-year; revenue from the Neuroscience portfolio was $2.288 billion, growing by 4.7%; revenue from the Medical Surgical portfolio amounted to $2.142 billion, reflecting a 7.0% increase; and Diabetes revenue was $610 million, rising by 9.7%.

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