There were a number of stories this week in the news that revolved around the treatment of peripheral artery disease. Peripheral artery disease (PAD) is when the arteries narrow and there is restricted blood flow to the limbs. Often times it is caused by the buildup of plaque in the artery walls. Medtronic and Shockwave Medical had promising studies released this week showing that their drug-coated balloons could help treat PAD while Covidien was cleared by the FDA for its directional atherectomy system.
Medtronic’s device, the IN.PACT Admiral drug-coated balloon, was shown to be highly successful in a trial that involved 331 subjects across 57 sites throughout Europe and the United States. The trial involved patients with PAD and diabetes and used a traditional balloon angioplasty to directly compare with Medtronic’s balloon. The study found that 82.2% of patients treated with the IN.PACT Admiral drug-coated balloon had restored blood flow through their problem arteries while only 52.4% of the traditional balloon angioplasty patients had theirs restored.
Shockwave Medical released clinical trial data at the Vascular Interventional Advances conference in Las Vegas that shows the effectiveness of its Lithoplasty balloon catheter at treating PAD. What makes Shockwave Medical’s catheter different is that it uses integrated lithotripsy, a form of mechanical energy used to break up kidney stones. This enables the catheter to disrupt superficial and deep plaque buildups. Primary results showed a 100% success rate, defined as the ability to achieve 50% or less residual stenosis and the average residual stenosis was 23%, while the average initial stenosis was 76%.
Covidien won 510(k) clearance from the FDA for its HawkOne directional atherectomy system. Directional atherectomy is a catheter-based minimally invasive treatment for PAD that removes the buildup of plaque. The HawkOne system has an advanced cutting mechanism that allows physicians to effectively treat the buildup of plaque. A recently published study showed that using this device resulted in 95% limb salvage in patients with critical limb ischemia.
It is an exciting time to be in the medical device industry with all of these new innovations. And it’s not just the large companies like Medtronic and Covidien that are making splashes in the market, but even the smaller companies like ShockWave Medical are showing they can make a difference. It is fascinating to see these miniscule devices that once were impossible to even imagine are now becoming more and more common throughout the industry.