Disclaimer:

There is a financial disclaimer at the end that is an important part of this report. This report discusses a company that makes medical devices. Nothing in it should be considered medical advice. DKI does not provide medical advice, and I am not a physician, medical professional or otherwise qualified to offer medical advice. If you are having a medical problem, we encourage you to consult with a physician.

 

Overview:

I spoke with an interventional cardiologist today. He handles both basic and complicated cases in the South Florida area. His focus is on cardiac procedures, but he also does peripheral cases where there are blockages in the legs or arms.

 

In his practice, about 25% of the cases he sees have excessive calcification which require the use of an advanced device to place a stent. As we saw in our January subscribers’ webinar with cardiologists Dr. Paul Thompson and Dr. Daniel Fram, they thought about 10% – 20% of cases had excessive calcification. These are estimates and the difference could be related to doing a back of the envelope calculation. Alternatively, the cardiologist I spoke with today works in Florida where there are more elderly people. As people age, calcification increases meaning the older someone is, the more likely it will be that there will be difficulty placing a stent.

 

Prior to Shockwave, he would use a drill device called a Rotablator. That device comes with a higher risk of complications including possible perforation of the artery which can cause highly negative outcomes including death. He now prefers to use a Shockwave device because it has fewer complications and is safer.

 

Both this cardiologist and Dr. Fram use the “RotaShock” procedure where they use a Rotablator to make a passage large enough to insert a Shockwave device and then switch to Shockwave. This has the benefit of being safer for the patient because there is less use of the Rotablator drill. It also enables placement of the Shockwave device which can safely remove calcification from the artery wall. Doing so results in better long-term outcomes for the patient and helps the stent get to maximum expansion.

 

Using both devices does involve additional expenses, but he hasn’t had difficulty getting the hospital to approve that, or getting the insurance company to reimburse. That’s because, while expensive, the “RotaShock” combination does produce better results for patients who require more complicated procedures.

 

The cardiologist mentioned that using the Rotablator gets him paid a few hundred dollars more because it requires advanced skill to use safely. I asked him if he thought that provided surgeons with an incentive to use the Rotablator instead of the safer Shockwave device. He said he had never heard of a surgeon making that choice. In his opinion, $300 of additional compensation isn’t close to enough to persuade a cardiologist to do a more dangerous procedure where a patient can die on the operating table in minutes due to a perforated artery. The risk isn’t worth it.

 

He also noted that using a Shockwave device requires less skill from a surgeon. In his practice, only 2 of 8 interventional cardiologists were using Rotablators. Now that Shockwave’s devices are available, 5 of the 8 can handle the more complicated cases with excessive calcification. Shockwave’s devices enable more surgeons to do high-quality difficult work. As a result, he sees Shockwave taking share and continuing to do so. He thinks Shockwave currently is used in about 50% of cases with excessive calcification and that this percentage will grow over time.

 

Shockwave claims they have a 2-4 year lead on the competition. This cardiologist said he hasn’t heard of any competing product on the way.

It is possible to place a regular stent in an ambulatory surgery center, or a physicians’ practice outside of a hospital. For anything more complicated, and especially when the use of a Rotablator is required, it’s crucial to be in a hospital. If something goes wrong, the patient can die in minutes and having the additional resources and support in a hospital can be necessary.

 

Peripheral procedures in the arm or leg carry less risk and have a greater margin of safety. Those can be done in ambulatory surgery centers as an outpatient procedure. In peripheral procedures, he thinks 25% or more have excessive calcification and require use of an advanced device.

 

He also thinks that peripheral procedures and the international markets are areas of growth for Shockwave. The non-US surgeons he talks to are using Shockwave devices. He believes Shockwave will continue to grow share in the next few years.

 

IR@DeepKnowledgeInvesting.com if you have any questions.

 

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