Contract manufacturing
It is no surprise, therefore, that the market for medical devices to diagnose or treat CVDs is expected to grow strongly in the next few years. According to Precedence Research, the global cardiovascular devices market was valued at $52.9bn in 2021 and is expected to exceed $92.5bn by 2030. “The market for cardiovascular devices is constantly growing and fast – as much as 6–8% each year,” says Christa Schnider, director of business development at Jabil Healthcare, which produces a long list of equipment for the cardiovascular device market, from radiofrequency generators for hospital ORs and heart/lung machines, to pacemaker communicators that sit on the patient’s bedside and balloon catheters to clear clogged arteries. Many different factors will likely contribute to that projected growth, but a very important one is the fact that a large number of countries have an ageing population, making more people prone to strokes and heart conditions. “This means demand for devices for diagnosis and treatment is growing,” says Schnider, pointing to technological advances like robotic surgery and more advanced implants as evidence. “Finally, more and more people are getting access to those treatments due to growing awareness and a higher level of wealth in society, which enables more people to get access to better healthcare,” Schnider adds. At the cutting edge of cardiovascular devices,
there’s no shortage of examples either. In 2021, Remo Care Solutions launched an AI-powered cardiac monitoring device; Angel Medical Systems announced the first commercial implantation of its FDA-approved heart attack warning system, ‘Guardian’; and the FDA approved the world’s first non-surgical heart valve treatment for paediatric and adult patients suffering from a native or surgically repaired right ventricular outflow tract (RVOT). In 2022, Biosense Webster launched the HELIOSTAR Balloon Ablation Catheter in Europe, which supports cardiac electrophysiological mapping of the atria and, when used with a compatible multi- channel radiofrequency generator, cardiac ablation.
Fertile ground for innovation As the global population continues to grow, and the average age in developed nations continues to rise, there is likely to be a growing incidence of CVD, which will encourage the adoption of even more technologically advanced cardiology devices for diagnostic and surgical use. At the same time, this will continue to reduce the cost of many critical cardiovascular devices used today – coronary stents being a prime example – and make current treatments increasingly accessible to a wider global market.
A recent study by the Harvard T.H. Chan School of Public Health (HSPH) showed that lower prices
Medical Device Developments /
www.nsmedicaldevices.com
A STELLAR idea?
Catheter ablation has evolved into an established therapeutic option that aims to electrically isolate the pulmonary veins (PVs) from the atrial myocardium. The traditional method comprises point-by-point radiofrequency current ablation guided by electroanatomical mapping and has proven to be effective and safe in experienced hands. However, balloon-based ablation allows for quick, easy isolation of the PVs in a single shot. One of the most prominent balloon-ablation devices is the HELIOSTAR RF balloon from Biosense Webster. In its STELLAR study, the company investigated the safety and efficacy of pulmonary vein isolation (PVI) using the HELIOSTAR Balloon Ablation Catheter in drug refractory symptomatic paroxysmal atrial fibrillation (AFib) – meaning cases of intermittent AFib that did not respond to treatment with pharmaceuticals. In the analysis, acute PVI was achieved in 98.8% of subjects and in 93% without additional use of focal catheters. Primary effectiveness at 12 months was 67.7% and >90% of patients were free from repeat ablation at 12 months. In addition, the rate of clinical success – defined in the study as freedom from 12-month symptomatic atrial arrhythmia recurrence – was 77.7%. The STELLAR study was an FDA-regulated investigational device exemption study conducted in the US, China and Italy to assess the safety and efficacy of PVI using the HELIOSTAR Balloon Ablation Catheter in drug refractory symptomatic paroxysmal AFib. An article in the journal Arrhythmia & Electrophysiology Review noted the
efficiency gained using RF balloons – isolating PVs within a minute as opposed to the two to three minutes of a cryoballoon. But the article said the long-term safety of such powerful devices remains to be seen, noting that in the previous RADIANCE trial that evaluated the one-year outcome and safety of the HELIOSTAR balloon, asymptomatic cerebral lesions were seen in 30% of patients, which is on the higher end of accepted ablation technologies. Gastroscopy also revealed asymptomatic oesophageal erythema in 13% of patients, which is also higher than reported for other ablation technologies. It should be noted that these outcomes fall within an acceptable range for ablation technologies, but it will be interesting to see if they’re consistent once the full STELLAR study results are released.
for coronary stents have fuelled a 43% increase in the number of heart operations in the Indian state of Maharashtra. As the market grows, there is increased incentive for medical device companies to invest heavily in research and development, so innovation should be rife in the coming years. For innovation to flourish, however, robust manufacturing processes – and the development of relationships with contract manufacturing organisations – will be crucial. Jabil is the world’s largest healthcare contract manufacturer. Headquartered in St. Petersburg, Florida, it has around 100 plants in 30 countries, and 260,000 employees worldwide. As part of its healthcare division, Jabil’s medical device business unit provides foundational expertise in manufacturing and supply chain solutions, combined with engineering and design capabilities for the development of a broad range of product solutions. The company manufactures devices that are used in many healthcare applications, including anaesthesia, cardiology, diabetes care, endoscopy, haemodialysis, neurology and patient monitoring. Among these, the cardiology segment is particularly important, given the growing market for devices that treat cardiovascular conditions. “Our portfolio includes self-assembly devices and entire products, as well as services for final testing, packaging and shipment to customers’ distribution
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