Abbott has received the CE Mark for TriClip™ Transcatheter Tricuspid Valve Repair System which is now approved for use in Europe and other countries that recognize CE Mark. The device is used as a non-surgical treatment for people with a leaky tricuspid valve, a condition known as tricuspid regurgitation (TR).
With the CE Mark designation, Abbott’s TriClip device is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available in the world.
Abbott is a global leader in developing transcatheter treatments for heart valve disorders and has brought to market three first-in-class therapies for structural heart disease: MitraClip for mitral valve repair, Tendyne™ for mitral valve replacement, and now TriClip to treat the tricuspid valve.
The tricuspid valve, often referred to as the “forgotten heart valve”, has three leaflets that control the flow of blood between the two chambers on the right side of the heart. When those leaflets do not close properly, blood can flow in the reverse direction – known as regurgitation – forcing the heart to work harder. When left untreated, TR can lead to conditions such as atrial fibrillation, heart failure, and ultimately, death. The condition is difficult to treat, however, and options for patients have historically been extremely limited. People with TR are typically older and suffer from multiple co-morbidities, making open-heart surgery a high-risk procedure.
The TriClip procedure repairs the tricuspid valve without the need for open-heart surgery. The device is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. This approach allows the heart to pump blood more efficiently, relieving symptoms of TR and improving a person’s quality of life.
“Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options,” said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the TRILUMINATE trial, which generated strong data that helped lead to the CE Mark of TriClip. “Abbott’s TriClip could profoundly impact how physicians treat these patients. The therapy is backed by data proving safety and performance, durability, and improved patient quality of life.”
The CE Mark for TriClip follows positive six-month data from Abbott’s pivotal TRILUMINATE study examining edge-to-edge repair technique using TriClip, which was published in The Lancet in November 2019. The study demonstrated that TriClip reduced severity of TR and was associated with strong improvement in functional capacity and in quality of life at six months.
TriClip builds upon the proven success of Abbott’s MitraClip device, which treats people with leaky mitral valves, or mitral regurgitation (MR). TriClip leverages the same clip-based technology as MitraClip but has a differentiated delivery system designed specifically for delivery to the tricuspid valve. A new, steerable guiding catheter system adapts to the right side of the heart, where the tricuspid valve resides, enabling the physician to effectively grasp and clip the leaflets of the tricuspid valve. Additionally, the TriClip device is available in two different sizes (NT and XT) to accommodate different patient anatomies.
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Carestream Health has introduced a new optional advanced metal artifact reduction software for its OnSight 3D Extremity System which captures high-quality, low-dose 3D extremity exams. This second generation of software provides enhanced flexibility depending on the metal content present and reduces the visual distortion caused by screws, implants, rods and other metal objects to create improved visibility. Image processing can be adjusted and optimized according to the amount of metal present. The software uses information from the original scan to eliminate the need for additional imaging studies, which reduces costs and lowers radiation exposure for patients. An intuitive touch screen interface allows technologists to adjust for either moderate or complex metal content. The metal artifact reduction software can be activated prior to the scan or it can be applied after the original reconstruction is complete. Both the original and corrected images are always available to view and compare. The OnSight 3D Extremity System also assists surgeons in detecting occult and non-union bone fractures. Unlike traditional CT systems, this cone beam CT system has a large-area detector that captures a 3D image of the extremity in a single rotation, which takes only 25 seconds. A patient simply places the injured extremity into a donut-shaped opening in the system. Since the patient’s head and body are not confined, patients do not experience the claustrophobia that often occurs with traditional CT systems. Dose is significantly reduced because only the affected body part is imaged. The compact extremity system can be installed in an exam room and plugs into a standard wall outlet.
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Two studies have been published that successfully evaluate the use of its Yumizen H500 hematology analyser for point-of-care testing (POCT) to enhance the care of oncology patients. With near-patient, full blood count results, patients undergoing chemotherapy can receive treatment without delay and greatly reduce their hospital/clinic exposure times. Both UK-based studies were presented at the recent ISLH 2018 (International Symposium on Technical Innovations in Laboratory Hematology) in Brussels.
The evaluation studies were performed by the Cardiff and Vale Health Board (CAVHB), University Hospital of Wales [1] and the Spire Bushey Laboratory, London [2] and can be viewed on the HORIBA Medical global website. Both studies demonstrated that the compact, easy-to-use analyser delivered at the POC clinically key parameters that showed exceptional correlation with larger laboratory-based hematology analysers. Blood samples from oncology patients may be abnormal, having low counts and atypical blood cells, therefore it is essential that near-patient testing does not compromise the clinical integrity of results.
The studies both found that in addition to speed and ease of use, the Yumizen H500’s functionality and audit systems fully adhere to ISO standards (both 15189:2012 and 22870:2016) with the same internal quality controls as larger analysers. This in turn ensured detailed, accurate results for timely and sound clinical decision making.
For example, the Cardiff study concluded that by using the Yumizen H500, “In CAVHB the potential for clinical improvement is potentially vast, average TAT (vein to report) for FBC is ~4 hours, this could be reduced to <15 minutes. This would mean that in certain patient groups (thrombocytopenic and anemic) they can request blood components earlier and be transfused more quickly, this in turn would reduce hospital stays. In neutropenic patients their treatment options could be considered more readily and reduce hospital/clinic exposure time in those that would not be appropriate for chemotherapy.”  With just three reagents and an intuitive touch screen user interface, HORIBA Medical’s Yumizen H500 compact hematology analyser is designed for ease of use; yet it offers a range of clinically key parameters, including: 5-population WBC differential, red blood cell parameters and platelet count. This makes the Yumizen H500 most suitable for rapid blood counting for use in POC settings for pediatric care and chemotherapy patients, as well as from emergency care to the routine laboratory.
The two POCT studies presented at ISLH 2018 can be viewed at:
https://www.horiba.com/en_en/products/by-segment/medical/

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