Product Review: TriClip Transcatheter Tricuspid Valve Repair System

Product Review: TriClip Transcatheter Tricuspid Valve Repair System




Cardiovascular diseases are one of the leading causes of death worldwide, but most of them could be prevented with proper medical interventions. However, the introduction of smart applications, far away monitoring, and minimally invasive approaches have been successful in targeting the gaps in vascular health care by technology and saving millions of lives. Many new treatment options are being developed to eliminate the need of open-heart surgery as it carries a high degree of risk. The arrival of transcatheter tricuspid valve intervention (TTVI) devices as an different treatment option for tricuspid regurgitation (TR) or the leaky tricuspid valve have revolutionized the field of structural cardiology. Designed to reduce TR severity by valve leaflet plication, the percutaneous coronary devices have attained a lot of recognition due to their ability to treat harsh TR in a minimally invasive way without posing the risk of harsh complications. Currently, 80% of mitral regurgitation treatments are being performed with the MitraClip/TriClip™ system worldwide to address the specific features of the transcupid valve anatomy.

Abbott’s TriClip™ is the first-of-its-kind transcatheter tricuspid valve repair clip device to receive CE mark clearance as a non-surgical treatment option for people with TR. The minimally invasive clip-based device is an iteration of the company’s highly popular and successful MitraClip used for transcatheter mitral valve. The next-generation clip-based therapy, also known as TriClip™ G4 consists of a leaflet grasping characterize and new clip sizes to adjust to and tailor repair of the rare anatomy of each patient. Leaving TR unaddressed for a long period can rule to atrial fibrillation, heart failure, or already death so Abbott’s TriClip™ serves as a appropriate option for patients with multiple co-morbidities. consequently, the device prevents the high-risk patients undergo the open-heart surgery, which could present a number of complications. The new-generation clip therapy can enhance the cardiologists’ ability to repair tricuspid valves safely and effectively, consequently dramatically improves the quality of life for people with harsh and symptomatic tricuspid regurgitation. Post-implantation of the clip device, the patients can considerably eliminate symptoms such as shortness of breath, fatigue, decline in endurance, ascites, and peripheral edema.

The six-month pivotal TRILUMINATE CE Mark study examining edge-to-edge repair technique using Abbott’s new clip therapy demonstrated a meaningful reduction in the severity of weakening TR, consistent symptomatic improvements and enhanced functional position of the heart. consequently, the physicians consider the device to be highly safe, lasting, and reliable for the treatment of TR in high-risk patients or people with moderate or harsh TR. The TriClip™ device has the possible to repair the tricuspid valve without open-heart surgery only by clipping together a portion of leaflets to reduce the blood flow. The minimally invasive approach allows the heart to pump blood more efficiently and relieve symptoms associated with the tricuspid valve leakage.

Although Abbott’s TriClip™ device is built upon the same technology of the company’s MitraClip transcatheter mitral valve therapy that is employed to treat leaky mitral valves, the next-gen device differs in terms of the delivery system. The new, steerable guiding catheter system is engineered to adapt the right side of the heart where the transcupid valve is present. To meet the needs of rare anatomies of patients, Abbott’s TriClip™ is obtainable in two different sizes (NT & XT). Currently, the TriClip™ is approved for use in Europe and other countries that recognize the CE mark.

The TriClip™ system consists of mainly two parts, steerable guide catheter (SGC) and clip delivery system (CDS). The CDS includes a steerable sleeve, delivery catheter, and wide chrome cobalt clip of 4 mm (NT size) and 7 mm (XT size) with articulated arms. The SGC in the new TriClip™ design contains two knobs for steering maneuvers. Besides, the steerable sleeve includes only one knob intended for deflecting the tip and reducing the radius of the distal curve. The modifications ease the bending and guiding of maneuvers into the right atrium. The device is used to clip the two leaflets together at the center and create two smaller openings to form a tighter seal. The upgraded TriClip™ allows clinicians to customize the procedure to each patient’s rare valve and independently grasp leaflets before fastening. With 100% implant success rate, the device can help to save time and costs of patients by reducing the need for hospitalization by 40%.

Other different for Minimally Invasive Tricuspid Therapy

Edward LifeSciences-PASCAL

The PASCAL device can be successfully alternation to reduce TR as it creates a new surface for coaptation of tricuspid leaflets, which helps in reducing leakage. The medical device consists of a foam-filled spacer that is inserted by axillary vein into the regurgitant orifice. PASCAL has a length of 42 mm and diameter of 12 and 15 mm and advocated for use in moderate-to-harsh TR. Its 22F delivery system permit easy manoeuvring in three planes and stabilizers lock handles for functional procedure. The major assistance of central spacer is that the surgeon does not need to pull the leaflets of valve as one would do during a traditional procedure. consequently, the implantation of the device helps to repair the valve by better distributing the forces of the system throughout valve leaflets and consequently help in efficient working of the heart.

The PASCAL repair system offers a minimally invasive approach for patients as the device is inserted by the groin area making an entry point of 0.7-0.8 cm. The independent clasping function of the PASCAL repair system provides some benefits to the physicians. During the surgery, the surgeon can individually control each side of the clasp machine, which could not be performed earlier. The technique allows the physicians to reopen one side of the clasp while keeping the other clasp in the stationary position, which helps to optimize its capture and reclose the system. The independent leaf capture method enhances the efficacy of the PASCAL system and provides optimal results. The patient can be easily extubated post-procedure and sent to normal ward. Unlike with valve surgery, the patient does not require pain medications and can be discharged within two days. After a week, the patient can already return to their daily activities and live a normal life.

The comparatively new tricuspid therapy by Edward Lifesciences, known as FORMA, has been designed specifically for the treatment of leakage in tricuspid leaflets, but the medical device is currently under clinical trials and has however to receive CE approval.

Conclusion

TriClip™ Transcatheter Tricuspid Valve Repair System is a promising technique that offers feasibility, safety, and excellent outcomes. In the coming years, the clip-based therapy is set to bring forward a paradigm shift in the management of tricuspid regurgitation (TR). However, the medical device needs to analyzed in more clinical trials to determine its efficacy against the tricuspid therapies. Also, the use of transcatheter tricuspid valve does not provide satisfactory results for patients with past valve surgery, PPML, and moderate to harsh organic or aortic valve diseases. So, new methods and techniques need to be devised to expand the scope of the treatment modalities for more patients with cardiovascular problems.

According to TechSci research report on “Global Interventional Cardiology Devices Market By Product kind (Angioplasty Balloons, Angioplasty Stents, Structural Heart Devices, Catheters, Plaque alteration Devices, Hemodynamic Flow Alteration Devices, Others) By End User (Hospitals & Clinics, Ambulatory Surgery Centers, Others) By vicinity, Competition Forecast & Opportunities, 2026″, the global interventional cardiology devices market is expected to grow at a meaningful CAGR during the forecast period. The growth can be credited to advancements in medical devices and rapid surge in the need for minimally invasive surgeries. Additionally, high need for novel products for the treatment of cardiovascular diseases to reduce risks and rising incidences of heart problems are contributing to the growth of global interventional cardiology devices market.




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