The regulatory pathway for Shockwave Medical’s Intravascular Lithotripsy (IVL) technology just received a huge jolt from FDA. The agency granted the Santa Clara, CA-based company breakthrough device designation for the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter.
The firm’s device is designed to fracture problematic calcium using sonic pressure to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle.
Shockwave’s technology is being evaluated in the DISRUPT CAD III, a prospective, non-randomized, multicenter global IDE study. The company said the study is approved to enroll 442 patients at 50 centers in the U.S. and Europe, and is led by co-principal investigators Drs. Dean Kereiakes and Jonathan Hill.
Shockwave Medical’s CEO Doug Godshall told MD+DI, “We remain on track to complete enrollment in the second quarter of 2020 and are a bit ahead of plan. In our most recent earnings call for Q2 we gave the update that investigators have enrolled 108 patients as of the end of June.”
Godshall said there was a pretty significant market for the technology.
“Due to the increasing prevalence of calcified cardiovascular disease, the market growth for plaque modification devices exceeds that of PCI procedure growth,” Godshall said. “We believe the safety, ease of use and efficient impact on calcium from our Shockwave C2 IVL catheter will result in rapid adoption and market expansion in markets in which our technology is introduced. We believe there is over a $2 billion total addressable market opportunity for our IVL System to treat coronary artery disease.”
Device Designations from FDA have been fast and furious over the past few weeks.
Early last month, B. Braun Intervention Systems was granted the designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis.
The list grew to include Galway, Ireland-based Perfuze, which won the designation for the Millipede Clot Ingestion System technology.
Concept Medical managed to bring home two designations within 30 days for the MagicTouch PTA, a Sirolimus drug-coated balloon catheter. The first indication was for the treatment of peripheral artery disease below-the-knee. The second indication was for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure.
And in this week alone, both Laboratory for Advanced Medicine (LAM) and Prescient Metabiomics were granted breakthrough designations for their respective cancer diagnostic tests.