A revolutionary new interventional cardiology system has made its debut on SA shores, and is scheduled for use in a surgical procedure at Netcare Union Hospital on 28 March.

Shockwave Medical’s novel intravascular lithotripsy technology is being brought to SA by one of SA’s leading vascular device distributors, Paragmed.

Shockwave IVL is a novel system that delivers localised pulsatile sonic pressure waves, modifying calcified lesions in a safe and reproducible manner. The mechanism is leveraging electrohydraulic-generated lithotripsy to produce high-speed sonic pressure waves that pass through soft tissue to selectively disrupt calcium. The concept adopted is similar to urologic extracorporeal lithotripsy, but IVL differs by expressing a focal field effect with reduced energy. IVL is designed specifically for vascular applications with the technology producing unfocused energy that creates a localized effect within the vessel.

The Shockwave IVL system integrates angioplasty balloon catheter devices with the calcium disrupting power of sonic pressure waves known as lithotripsy. Each IVL catheter incorporates multiple emitters with the touch of a button after the balloon is inflated, the emitters produce therapeutic sonic pressure waves that are inherently tissue-selective.  These pass through the balloon and soft vascular tissue-disrupting the calcified plaque inside the vessel wall and creating a series of micro-fractures. When the calcium has been modified, the vessel can be dilated using low pressures, thereby enabling even historically challenging patients to be treated effectively with minimal injury to the vessel.

Although the vast majority of coronary stenoses can be dilated with conventional balloon angioplasty, there are occasions where this is either impossible or unsafe. Most commonly, non-dilatable lesions are encountered in calcified vessels, very often in older patients.

Where such a lesion is encountered, sometimes unexpectedly, until now the risk of angioplasty and stenting has been significantly increased. Very high balloon pressures can be attempted, with the risk of balloon or vessel rupture. Cutting and scoring balloons can be attempted, but are often inadequate to reach the tight stenosis, or to dilate it effectively. For many lesions the only effective treatment until now has been rotational artherectomy, a complex mechanical technique available in a few facilities only (and used by few operators). Where stents are placed in inadequately prepared non dilatable lesions major complications can and do result.

IVL offers a widely applicable and safe solution to many calcified lesions. This makes some previously untreatable lesions treatable and makes many lesions more simply or easily and successfully treatable. Unlike rotational artherectomy, IVL can also be used to treat large lumen calcified vessels, where the size of a rotor burr may be inadequate to disrupt deep calcium.

The first case in South Africa using this ground-breaking technology is scheduled to take place at Netcare Union Hospital on the 28th March 2019.

Paragmed has signed an exclusive distribution contract with Shockwave Medical to bring intravascular lithotripsy to South Africa.