Shockwave Medical (SWAV) Announces IVL Studies' Positive Results

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Shockwave Medical, Inc. SWAV recently announced two new publications that reported favorable and consistent outcomes with coronary intravascular lithotripsy (IVL) in both nodular and eccentric calcium. Each publication reported separate patient-level pooled optical coherence tomography sub-analyses of the company-sponsored Disrupt CAD (coronary artery disease) clinical studies.

The IVL in Eccentric Calcium and IVL in Nodular Calcium-related publications were published in Circulation: Cardiovascular Intervention and JACC: Cardiovascular Interventions, respectively.

The latest positive study outcomes are expected to be significant stepping stones for Shockwave Medical in expanding its footprint in the CAD treatment space and solidifying its position worldwide.

Significance of the Publications

Per an expert associated with the first publication related to IVL in Eccentric Calcium, IVL was initially adopted in clinical practice because of its ability to modify concentric calcium in a safe and predictable manner. However, it is currently observed that the utility is increasing as the consistency of the safety and efficacy outcomes related to IVL expands across calcium arcs.

The expert believes that the shift in clinical practice has been crucial in addressing the limitations of atherectomy technologies in modifying eccentric calcium because with IVL, there is a tool that can modify the eccentric calcium and increase vascular compliance to the greatest effect while minimizing procedural risk.

With respect to the second publication, related to IVL in Nodular Calcium, the new and encouraging acute data with IVL reconfirms the safety of IVL with no procedural complications in lesions with calcific nodules, which is generally a high-risk setting.

Industry Prospects

Per a report by Research and Markets published on yahoo! finance, the global CAD market is expected to reach $38.17 billion in 2028 from $22.94 billion in 2022 at a CAGR of approximately 8.9%. Factors like the rapid growth in the elderly population, unhealthy lifestyles and a rising number of people suffering from obesity, diabetes and high blood pressure are likely to drive the market.

Given the market potential, the latest favorable publications are expected to provide a significant boost to Shockwave Medical’s business globally.

Notable Development

In August, Shockwave Medical reported its second-quarter 2023 results, wherein it registered a solid uptick in its quarterly revenues, which was driven by an increase in the purchase volume of catheters in both the United States and internationally. Management’s optimism about the continued clinical acceptance and penetration of IVL was also promising.

Comparison With Peers

A notable name in the medical device industry is Medtronic plc MDT. In August, MDT reported its first-quarter fiscal 2024 results, wherein its organic revenue results reflected broad strength across businesses and geographies, driven by execution, innovation and improved underlying fundamentals. During the quarter, Medtronic’s Cardiovascular revenues at constant exchange rate were also robust, with all three divisions reporting organic growth in the quarter.

In May, MDT announced the positive findings of its investigational Extravascular Implantable Cardioverter–Defibrillator Study.

Another notable name in the niche space is Abbott Laboratories ABT, which is also Shockwave Medical’s peer. This month, ABT reported its third-quarter 2023 results, wherein it registered broad-based growth in the underlying base business. Within the Medical Devices segment, Abbott delivered double-digit organic growth in Diabetes Care, Electrophysiology, Structural Heart and Neuromodulation in the reported quarter.

Last month, Abbott completed the acquisition of Bigfoot Biomedical, a developer of intelligent insulin management systems for people with diabetes.

Boston Scientific Corporation BSX, another peer of Shockwave Medical, is also a renowned name in the medical device space. Last month, BSX received the FDA’s approval for the latest-generation WATCHMAN FLX Pro Left Atrial Appendage Closure Device.

In July, Boston Scientific announced its second-quarter 2023 results, wherein it registered a strong year-over-year improvement in organic sales, indicating a solid rebound in the legacy business even amid several macroeconomic issues. BSX’s revenues from its Cardiovascular segment and sub-segments (Cardiology and Peripheral Interventions) were also strong.

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