Latest News

As part of the purchase, Edwards acquires JC’s J-Valve System, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation. Credit: Shutterstock / MacroEcon

Edwards Lifesciences has bought US-based transcatheter aortic valve replacement (TAVR) company JC Medical from Singapore-based Genesis MedTech for an undisclosed amount.

As part of the purchase, Edwards acquires JC’s J-Valve System, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation. Edwards paid upfront, plus potential sales-based contingent milestones.

Genesis MedTech will maintain the exclusive right to manufacture the J-Valve system in China.

Following the announcement, Edwards Lifesciences’ stock value dropped slightly from $69.34 per share down to $67.92 the following day but still maintained a five-day high of $68.26.

The acquisition comes following a busy year of acquisitions for the US medical device giant, with the company picking up Israeli company Innovative Bio-Medical for its transcatheter mitral valve replacement (TMVR) business for $300m last month. Edwards also announced the strategic acquisitions of JenaValve Technology and Endotronix in a $1.2bn upfront payment. 

The US Food and Drug Administration (FDA) has issued a Class I recall for Defibtech’s RMU-2000 ARM XR chest compression device.

The regulatory agency has tagged the recall as the most serious type and will see the affected devices removed. The recalled devices have been linked to one reported injury and a case of patient death. 

The device malfunction has been linked to “a problem with the device’s motor”, as per the FDA recall notice.

The defective motor can cause the automated device to stop chest compressions leading to serious adverse events including patient injuries, delay of therapy and death.

Defibtech, a Nihon Kohden company, first issued an urgent medical device safety removal letter regarding the defect last month. The company recommended that its customers should identify and quarantine the affected units which can then be returned to the company. The recall affects 211 devices, of which 174 were sent across the US and the rest were exported to Japan. 

Musculoskeletal solutions company Globus Medical has commercially launched the ADIRA XLIF Plate System for enhancing lateral plating in spinal surgeries.

This system is the first to be compatible with the company’s comprehensive lateral interbody portfolio. 

The ADIRA XLIF Plate System aims to refine lateral plating by providing simplified insertion workflows along with a rigid coupling mechanism.

It is designed to align plates confidently over interbody spacers, thus enhancing the stability of the construct. The system is compatible with bone screws and lateral MIS anchors, providing procedural versatility for bone fixation options and various interbody spacer types. Globus Medical Spine president David Hole said: “This launch represents an important milestone in our integration roadmap.

“Through the system’s ability to be paired with our industry-leading Globus and NuVasive interbody spacers, ADIRA demonstrates our continued commitment to accelerated procedural innovation in lateral spine surgery.” 

US-based kidney care company Calyxo has announced the results of a multicenter study finding that its central venous access catheter (CVAC) device for the treatment of kidney stones drastically cut down on the rate of patients returning to hospital.

Presented as part of the 41st World Congress of Endourology and Uro-Technology (WCET) in Seoul, South Korea, the ASPIRE study saw 95% of participants who used the company’s CVAC device receiving steerable ureteroscopic renal evacuation (SURE) saw no adverse events following treatment. The device and SURE procedure were measured against patients receiving a standard ureteroscopy treatment.

According to Calyxo, the SURE procedure is exclusively performed with the CVAC system and is the only complete stone clearance solution that enables effective and efficient kidney stone removal. The ASPIRE study saw 123 subjects followed for 12 months after treatment, with only two patients experiencing an adverse event. 

Neuralink grabbed much of the ‘brain chip’ headlines earlier this month when the company’s founder and owner Elon Musk announced the second successful implant of its device, but the tech startup is far from the only party that has made advancements in the space.

Brain-computer interfaces (BCIs), also called brain-machine interfaces, are chips implanted in brain tissue that take brain signals and translate them into commands. The signals are then relayed to a secondary, external device, which then carries out a specific function. At present, the main application is in the neuromuscular field, meaning paralysed patients can move muscles just by thoughts.

Neuralink has captured much of public interest around this technology, owed in part to Musk’s stature as the richest person in the world. His company, however, has implanted just two paralysed patients with its device called Telepathy. Other companies in the space are further into their clinical journey.