The peripheral vascular device space has been focused on the drug-coated balloon (DCB) segment in recent months. First C.R. Bard, then Medtronic, gained FDA approval for their respective DCBs in late 2014. More recently, Covidien's Stellarex DCB was sold to Spectranetics. Spectranetics is now poised to enter the European DCB market and the battle between C.R. Bard and Medtronic for DCB market share in the US is on. But while the spotlight was on DCBs, a small company with a novel technology slipped into the European PTA balloon catheter market.
Shockwave Medical's Lithoplasty balloon uses electromechanical lithotripsy to break down calcified lesions, while leaving surrounding tissue unharmed, and balloon angioplasty to push open the vessel. Lithotripsy is commonly used as a safe and effective method of breaking up kidney stones and Shockwave has adapted this technology to a balloon platform, such that the electrodes are built directly into the center of the balloon. Overall, the Lithoplasty balloon provides multiple advantages over existing devices. Current alternative options for treatment of calcified lesions are atherectomy devices (mechanical or laser) and cutting (or scoring) balloons. Because PTA balloons are routinely used for interventional procedures, physicians will be able to test out this new technology without having to be trained on an entirely new technique the lack of physician training on atherectomy devices has been a restricting factor for adoption of these devices. Atherectomy devices are also very expensive and generally not reimbursed in Europe. On the other hand, while cutting balloons utilize a balloon platform, there is a shortfall in clinical evidence to support their use. Another issue with cutting balloons and atherectomy devices is that they act primarily by scraping away plaque using mechanical force, a method that can sometimes cause trauma to the surrounding tissue. Electromechanical lithotripsy breaks down the plaque without any physical movement of the device in the vessel, other than balloon dilation, thus diminishing the possibility of physical trauma. Finally, the Lithoplasty balloon affects both superficial and deep calcium, whereas cutting balloons and atherectomy devices target only superficial calcium. Shockwave Medical, therefore, stands in a unique position when it comes to this niche market.
The adoption of the Lithoplasty balloon will ultimately come down to two factors: clinical trial data and the device price. Results from the single-arm DISRUPT PAD trial, which included 35 patients, showed both safety and efficacy of the device and these results were used to obtain CE Mark. However, larger studies will be necessary for entry into the US and data from upcoming trials will influence physician uptake in Europe (and globally) as well. Pricing of the device will also be crucial. As mentioned earlier, the price of atherectomy devices is a limiting factor and Shockwave Medical will want to offer a more affordable option than what is currently available.
Finally, you have to think about the eventual fate of this company. As a small company with a very niche technology, it is a typical target for acquisition. And I can't help but think that perhaps Spectranetics already has an eye on it. After all, Spectranetics has an atherectomy device on the market and acquired AngioScore in 2014, a company that had a scoring balloon on the market as well as a drug-coated scoring balloon in the pipeline. Add to that a Lithoplasty balloon and you've got a trifecta for calcified lesion treatment. Only time will tell if this theory will come to fruition.