Product News

Smart glasses guide remote support for pioneering TAVI procedure

The UK’s first remotely-supported transcatheter aortic valve implantation (TAVI) using smart glasses for remote guidance has been performed at the Essex Cardiothoracic Centre (CTC) at Basildon Hospital (Basildon, UK).

During the procedure, nurses who were wearing the smart glasses are guided remotely through a complex multi-step procedure by experts seeing exactly what they see. The glasses enable heart staff to receive real-time advice from anywhere in the world as they share a live feed from the operating theatre through a highresolution camera on the smart glasses.

Previously, staff were advised by a clinical expert from Boston Scientific present in the operating theatre, but they can now be remotely guided by the expert via the smart glasses from anywhere in the world, helping save time for patients and staff.

Rohan Jagathesan, medical director at the Essex CTC, said: “This new innovative equipment allows us to be more independent and to carry out more procedures, and means we can treat patients more quickly as we do not need a specialist to come to the hospital.We can also use the smart glasses to train our staff during a simulated procedure and further develop their skills, helping to improve the service we give to our patients.”

Abbott’s Epic Max stented tissue aortic valve gains US FDA approval

Abbott has announced that the US Food and Drug Administration (FDA) has approved the company’s Epic Max stented tissue valve to treat people with aortic regurgitation or stenosis.

Epic Max is designed to achieve excellent haemodynamics, or blood flow, and its low-profile frame facilitates potential future transcatheter interventions for patients, Abbott said in a press release. This new valve is built on the Epic surgical valve platform, leveraging its long-term performance and durability.

“The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement,” said Joseph Bavaria (University of Pennsylvania, Philadelphia, USA). “Abbott’s Epic Max design optimises blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”

Adept launches Adducted Arm Scoop product for use during image-guided procedures

Adept Medical has launched the Adducted Arm Scoop—an improved solution for supporting the adducted arms of supine patients during imageguided procedures.

Adept’s new, “extremely durable” Adducted Arm Scoops are purposedesigned, providing security and comfort on narrow imaging tables, as per a press release.

Moulded with gentle, curved edging to reduce the likelihood of pressure injury and improve handling, the ergonomic design allows patients to comfortably rest their arms at their side with assurance. The ideal height, extending just above the arm, allows access and ease of cable and line management during procedures, Adept also claims.

“After 10 years developing solutions for interventional cardiology/ radiology teams, listening to their needs, and observing how they care for their patients, it became obvious that existing arm supports could be improved immensely,” said Mike Oxborough, lead product designer at Adept. “Typically made from folded plastic sheet, they appeared to have very little thought put into design and were almost an afterthought, which is strange given they are an essential component for achieving patient comfort and safety on narrow imaging tables.

“Common complaints from nurses and MRTs [medical response teams] were that the arm boards would crack or break too easily, were expensive to replace, or were simply too flexible to support the heavy arms of larger patients. Improving durability was key, so selecting a material with superior chemical resistance was critical to prevent stress-cracks resulting from exposure to disinfectants used between patients.

“We wanted to create a product that would be more rigid, more durable, would look and feel like it had been designed for the job, and could be purchased for the same price or less than existing boards. With the Adept Medical Adducted Arm Scoop, we have achieved that.”

The Adducted Arm Scoops are quick and easy to install, according to the release. They simply slide under the mattress and are secured by the patient’s weight. Designed for use with existing lab and imaging equipment, they are compatible with any magnetic resonance (MR), computed tomography (CT) or C-Arm imaging tables.

OPN NC “super-highpressure” coronary

balloon launches in USA

SIS Medical AG has announced the launch of its OPN NC percutaneous transluminal coronary angioplasty (PTCA) dilatation catheter with ‘TwinWall’ technology in the USA.

“The product extends treatment options by high performance and safety as well as providing success rates where other balloons fail,” SIS Medical said of the device in a press release. The catheter is to be distributed by Worldwide Innovations & Technologies, which is headquartered in Lenexa, USA.

SIS Medical AG has developed the Twin-Wall technology, which it says provides a super-high-pressure resistance with a rated burst pressure of 35atm with a very low compliance. These features allow for preparation of challenging lesions prior to stenting without over-dilating of the blood vessel, the company says. The device can also be applied for post-dilatation of under-expanded stents.

OPN NC coronary balloon is the only super-high-pressure coronary balloon rated with 35atm which has received 510(k) clearance from the US Food & Drug Administration (FDA), SIS Medical claims.

The first US procedure using the device was undertaken by Philippe Genereux (Morristown Medical Center, Morristown, USA). “I was extremely satisfied with the performance of the OPN NC balloon,” said Genereux. “We were successful in efficiently treating multiple patients with very complex and calcified lesions. The OPN NC balloon is an essential tool for operators treating resistant lesions, restenosis, or to treat acutely under-expanded stent, and is a true cost-effective technology compared to other devices.”

First US implant of LuxValve Plus transcatheter tricuspid valve performed in Detroit

The first transcatheter tricuspid valve replacement procedure in the USA using the LuX-Valve Plus (Jenscare) device for the treatment of symptomatic tricuspid valve disease has been performed by interventional cardiologists at Henry Ford Hospital, Detroit, USA.

Pedro Villablanca and Brian O’Neill successfully performed the first US procedure for Norma O’Connor, an 80-year-old Detroit-area woman with severe tricuspid regurgitation, when it became evident that no other means would work. Traditional valve replacement was not medically viable for the patient, who was deemed to be a high risk for surgery.

“These are patients with severe tricuspid regurgitation who have no other options available to them in the USA, based on the anatomy of their native valve and medical complexities,” said Villablanca.

Merit Medical expands SwiftNinja steerable microcatheter offering

Merit Medical has announced the expansion of its SwiftNinja steerable microcatheter product line. New sizes include a low-profile 2.4Fr distal diameter option in 125cm and new longer 150cm lengths.

The 180-degree articulating microcatheter is designed to provide access to challenging peripheral and coronary vasculature without the use of a guidewire. It is part of the broader Merit Vascular portfolio that includes sheath introducers, inflation devices and embolics.

“Unlike conventional microcatheters that are limited to a set shape, the steerable SwiftNinja is really a gamechanger,” said Jason Hoffmann (New York University, New York, USA), and consultant for Merit Medical. “The tip shape and angle can be changed in real time while inside a patient, allowing for shorter procedures with less radiation exposure. Without the need for a guidewire, there is the potential for significant cost savings as well—all of which benefit the patient. The SwiftNinja has paved the way for better embolization care.”