Calcium Cracking in Arteries Using Sound Waves: Interview with Scott Shadiow of Shockwave Medical

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Shockwave Medical, a California-based medical technology company, has developed a technique called intravascular lithotripsy, which involves supplying sound waves to the calcified plaque of an artery in the same way that sound waves have been used to treat kidney stones. for many years. The idea is to safely break the calcified deposits so that a stent can be inserted to open the artery.

At present, calcified coronary arteries are usually treated with high-pressure balloons, which can sometimes struggle to disrupt calcified deposits and the high pressure involved can lead to safety issues. Other techniques include using small drills to remove calcium, but they are difficult to use safely and small chunks of calcium that are displaced can cause blockages elsewhere.

This latest technology, which has it has recently been approved by the FDA for use in the U.S., it applies sound waves to crack calcium, allowing subsequent low-pressure expansion of the artery and placement of the stent. The company claims the technique is safer and easier to use than many existing approaches and has recently validated the safety and efficacy of Shockwave’s IVL coronary system. DISRUPT CAD III study.

Medgadget He had the opportunity to speak with Scott Shadiow, senior director of Shockwave Medical, about the technology.

Conn Hastings, Medgadget: Please give us an overview of calcified coronary arteries and the problems they cause to patients.

Scott Shadiow, Shockwave Medical: As people with heart disease grow and their disease progresses, plaque in the arteries can progress to calcium deposits. These bone-like structures can reduce the artery and restrict blood flow, and can eventually cause a complete blockage. Obviously, this creates cause for concern, as reduced blood flow prevents the heart from functioning efficiently and causes chest pain to the patient. When this happens, doctors often use stents to open the artery and restore blood. However, of the approximately one million U.S. patients who undergo stent procedures each year, up to 30 percent have calcified lesions that increase their risk of adverse events in the acute procedural context and result in worse long-term clinical outcomes.

Medgadget: How is the state currently treated? What are the disadvantages of these approaches?

Scott Shadiow: When hardened calcium is present inside the plaque, doctors have conventionally relied on two treatment options prior to stent implantation to prepare the lesion: high-pressure balloons or atherectomy, but both present limitations and safety risks. High-pressure balloons are the most common method of treatment and use high-pressure to try to break down calcium so that the container can expand with stent implantation. However, the thick, circumferential calcium of an artery can be resistant to high pressure and can damage the artery by tearing soft tissues or even causing a puncture in the artery. The other treatment option is atherectomy, a technically demanding approach that uses a tiny drill that spins at over 125k RPM to clear calcium from the arterial wall so the artery can expand. As expected, operating a small, high-speed drill into the patient’s artery is very difficult to master unless done regularly. It can cause distal embolization of calcium as well as perforations. Although treatment is available for several decades, it is not used frequently (<5% of all stent procedures) due to its complexity and potential to produce adverse outcomes for the patient.

Medgadget: How does shock wave intravascular lithotripsy work? What are the advantages of this approach?

Scott Shadiow: Intravascular lithotripsy, or IVL, is a new adaptation of extracorporeal lithotripsy, an approach used for decades to safely break kidney stones. It uses sound pressure waves, also known as shock waves, that pass through the soft arterial tissue and preferentially disrupt the calcified plaque creating a series of fractures. After calcium has cracked, the artery can be safely expanded at very low pressure and a stent can be implanted to restore blood flow with minimal trauma to normal arterial tissue. What makes IVL unique is the fact that it offers doctors an intuitive treatment option that can safely modify calcium, reducing the risk of perforations and distal embolization, all on a platform they are accustomed to using. in all cases: balloon catheter.

Medgadget: Please give us an overview of the recent DISRUPT CAD III study.

Scott Shadiow: Our recent FDA approval (February 2021) for IVL in coronary arteries was largely based on the results we observed in the DISRUPT CAD III study. It was a global, prospective, multicenter, one-arm FDI study, designed to evaluate the safety and efficacy of the Shockwave coronary IVL system. The results were presented in a last-minute clinical session at last fall’s TCT 2020 virtual conference and published simultaneously in Journal of the American College of Cardiology (JACC). The study included 384 patients worldwide who had severe coronary calcification and needed modification for proper stent delivery and expansion. The study concluded that coronary IVL facilitated stent implantation safely and effectively in almost all patients, leading to a low risk of complications: perforation (0.3%), major dissection (0, 3%), abrupt closure (0.3%) and slow flow / no reflux (0 percent) at the end of the procedure. Overall, the results exceeded the expectations of researchers and the medical community, as at that time they eagerly anticipated FDA approval by the FDA in the United States. We expect to present the one-year results at TCT later this year, as patients will be followed for two years to complete the study.

Medgadget: Congratulations on the recent FDA approval. Where has the technology been most approved and how have patients and doctors received it so far?

Scott Shadiow: IVL coronary application has been widely adopted in Europe since it was launched in mid-2018, with more than 30,000 patients undergoing a coronary procedure using Shockwave technology since then. We have also launched the technology in certain countries in the Middle East, South America and the Asia Pacific. Our largest market is the US, where we have just received recent FDA coronary approval. This was a significant milestone for the benefit of both our client physicians and the patients they care for. Since the introduction of the technology, the response we have received from clinicians around the world has been overwhelmingly positive, as its incorporation into the technology exceeds our own expectations in every market we launch. We feel it is an opportunity once in a career to introduce a technology that is truly new, while at the same time predictably safe and easily intuitive. Doctors can pick it up and succeed in your first case. It is not every day that you have a technology with an unmet clinical need so clear that you can use a wide variety of physicians, regardless of their prior training or skill level.

Medgadget: How does technology work in peripheral arterial disease (PAD)? Is it easier to access and treat calcified plaque in the arteries of the leg?

Scott Shadiow: Fundamentally, the technology works equally well in PAD as in coronary artery disease, as it is the same mechanism of action for both arterial beds. In fact, we received peripheral approval a few years before we received our coronary approval. We have different versions of the product for each application to suit the size and length of the artery, but calcium, both superficial and deep, is similar to the two beds of the vessels. From an access perspective, both peripheral and coronary applications can be accessed by both transfemoral and trans-radial routes, and similar challenges exist in both ship beds from a treatment perspective. What differentiates the two treatments is that in the coronary artery, IVL is almost always followed by a drug elution stent, whereas in the periphery, IVL can be used as an independent treatment or followed by a drug coating underneath or a stent. The technology really matches the doctor’s preferred algorithm when dealing with different anatomies.

Medgadget: What payment options are available to providers?

Scott Shadiow: For coronary technology, given our approval as part of the Advanced Device Designation Program, it was qualified for outpatient transient transportation (TPT) payments from the Centers for Medicare & Medicaid Services (CMS) and for new technology. additional payment (NTAP). Our TPT was effective July 1stc and our NTAP will begin on October 1stc. These programs will allow hospitals to reimburse at least part, if not all, of the costs of the technology, in addition to the basic procedure. We applaud CMS for connecting these programs, which created a new avenue to help increase access to innovative products to patients who need them most. With each of these programs running for three years, Medicare will have the time to determine which of the most appropriate long-term reimbursement should be based based on your data collection.

Link: Shockwave Medical Company Home …

Flashbacks: Shockwave lithoplasty system is already eliminated in the EU for the treatment of coronary artery disease; Shockwave PAD balloon catheters with CE-marked lithotripsy technology; Shock wave lithoplasty for peripheral vascular disease eliminated by the FDA; The Shockwave S4 catheter shakes the calcified plaque from the peripheral arteries





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