Device developer FastWave Medical is working to advance intravascular lithotripsy therapy for peripheral and coronary artery disease.
By Tristan Tieso, FastWave Medical
Cardiovascular disease, including peripheral artery disease (PAD) and coronary artery disease (CAD), affects millions of people worldwide. Resulting from obstruction in one or more arteries, these conditions are often complicated by the presence of calcified plaque.
The prevalence of arterial disease has profound implications for society. Patients experience physical limitations like reduced mobility and discomfort, all of which directly impact their daily activities and independence. There’s also the economic strain these diseases put on patients and healthcare systems due to the long-term nature of treatment.
Advances in medical technology have brought forth novel treatments for PAD and CAD such as balloon angioplasty, stenting, and atherectomy. However, these techniques have not been able to fully address complex calcification. This gap in treating these diseases underscores the pressing need for more innovative solutions.
Understanding arterial diseases and vascular calcification
Arterial disease primarily encompasses conditions like PAD — affecting vessels of the lower extremities — and CAD — affecting vessels in the heart — leading to partial or complete obstruction of one or more arteries. These diseases tend to coexist in many patients, intensifying the therapeutic challenge.
Medial calcific plaque further complicates PAD and CAD treatment. This plaque in the middle layer of the artery is associated with vessel stiffening, much like how a pipe hardens when there’s buildup inside.
On the other hand, intimal calcium, which is close to the inner surface of the artery, is associated with obstruction and embolization, like a clog in a pipe that prevents flow.
The prevalence of calcification increases with age and correlates with hypertension and other cardiovascular risk factors. The presence of other such conditions presents a significant challenge in treating arterial disease.
Current treatment methods and their limitations
Current endovascular treatment methods such as balloon angioplasty, stenting, and atherectomy help to some extent. However, they are all ineffective in addressing complex artery diseases, especially medial calcium.
For example, significant calcium burden makes it difficult for devices to traverse the vasculature, inhibiting stent apposition and expansion.
High-pressure balloons may be used to fracture calcium and achieve luminal gain, but they may also lead to complications such as vessel dissection and perforation.
Atherectomy devices can effectively treat intimal calcium but are less effective against medial calcium and may cause embolism, dissection, and perforation.
Given these limitations, there is a clear and unmet need for innovative approaches to address complex calcium. This brings us to a promising new modality in the field of vascular treatments: intravascular lithotripsy (IVL).
The promise of intravascular lithotripsy (IVL)
IVL offers a fresh approach to treating severely calcified plaque in both coronary and peripheral vessels. It works by delivering acoustic pressure waves within the vasculature that safely pass through soft tissue, disrupting hard calcium. This allows subsequent dilation of the vessel at low balloon pressures.
The foundation of the IVL catheters are the multiple lithotripsy emitters that generate shock waves. They’re strategically located within an integrated balloon that inflates and expands inside an artery.
The angioplasty catheter is connected to a generator, a sort of “command center” that orchestrates the delivery pulses in a predetermined order. When the generator triggers a discharge of energy to the emitters inside the balloon, the fluid within vaporizes almost instantly. This sudden vaporization (or cavitation) generates sound pressure waves.
These waves of sound energy flow within the tissues of the artery, regardless of how complex the terrain is. When a sonic pressure wave hits soft tissue, it doesn’t cause any harm. But when it hits the stiff, hard calcium deposits, it cracks and disrupts them. The end result is that IVL is effective at treating both superficial and deep calcium deposits.
What’s impressive is that the calcium isn’t pulverized — it’s simply disrupted. The fragments remain right where they are, held in place by the artery’s internal elastic lamina, a thin layer that acts like a membrane. In short, the IVL technique enables physicians to selectively treat the hardened arteries without damaging soft, healthy tissue.
The advantages of IVL technology
In terms of its design and operation, IVL technology is quite similar to traditional percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) devices. This familiarity makes it a more comfortable choice for professionals accustomed to using these common vascular treatment tools.
A key difference with IVL systems, however, is how they generate and use pressure. While typical angioplasty balloons need high pressure to expand a blocked or narrowed artery, IVL balloons take a gentler approach, working efficiently under low pressure. This way, they reduce the risk of causing unintended damage to otherwise healthy tissue.
Moreover, by emitting targeted pressure waves, IVL can effectively break down both medial and intimal arterial calcium, enhancing the overall effectiveness of the procedure.
Introducing FastWave’s IVL technology
FastWave Medical is developing a next-level IVL platform designed to improve upon current technology on the market.
We’re expanding our device offerings to accommodate a broader range of patient needs. This includes increased catheter energy pulses and additional balloon sizes with enhanced rupture resistance and improved crossability.
Recognizing the drawbacks of the existing IVL generator, we’re also providing real-time, intra-procedural data directly to physicians, delivering critical insights that help guide treatment during procedures.
Finally, acknowledging the economic burden of cardiovascular diseases and their treatments, we engineered our system with cost-effectiveness in mind.
Through these steps, we aim to allow physicians to treat PAD and CAD with more consistent and predictable ultrasonic pressure and a more user-friendly system.
As we continue to innovate and develop this technology, we are confident FastWave’s IVL solution will revolutionize the treatment of vascular calcium, providing a safer, more efficient, and more effective approach for physicians to treat patients suffering from arterial disease.
The future is bright for those affected by arterial disease as we continue to make strides in addressing complex CAD and PAD. We are excited to be at the forefront of this groundbreaking technology and even more so about the potential to make a difference in the lives of patients around the world.
Tristan Tieso is chief operating officer of FastWave Medical, an early-stage medical device company developing novel intravascular lithotripsy (IVL) systems. Tieso has spent her entire career leading product development programs for medical device companies ranging from startups to multinational strategics.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.