Cardiovascular Systems, Inc. (CSI) has received approval for its second-generation stent delivery device in the U.S. and Japan. The approvals tee CSI up to begin selling the coronary artery disease device in the U.S. this summer.
CSI secured the regulatory clearances on the strength of data from a 100-person clinical trial of its Diamondback 360 Coronary OAS Micro Crown. The trial assessed the rate of major adverse cardiac events in patients with severely calcified coronary lesions who underwent treatment with the OAS Micro Crown device.
After one month, 85% of participants were free from major adverse cardiac events. That figure fell to 77.8% after one year, primarily because of an increase in the revascularization of target lesions and vessels. But given the difficulty of treating patients with severely calcified coronary lesions, CSI still thinks the device can carve out a slice of the market.
Like CSI’s OAS Classic Crown, the micro device is designed to reduce coronary arterial calcium using differential sanding and centrifugal force. The difference is CSI designed the micro device to cope with tight, calcific lesions and vessels of up to 4mm.
CSI is planning a limited rollout of the device in the U.S. this summer. And its Japanese distribution partner Medikit is gearing up for a full introduction in that territory next year. The introductions could build on the momentum of CSI’s coronary unit, sales at which grew 51% year on year in the second quarter.
The two approvals contributed to a busy week for CSI. On Wednesday, the day before CSI revealed the approvals, a judge in Minnesota dismissed a lawsuit alleging the company misled investors. The suit accused CSI of misleading investors about off-label device promotion and illegal kickback schemes, but the judge ruled it lacked enough detail to prove its allegations.
Last year, CSI agreed to pay $8 million to settle a separate suit that made similar allegations. Those allegations were based on comments by a former CSI district sales manager. CSI was accused of demanding attendees at all-expenses-paid training programs use it products, and of making sham speaker payments to high prescribers.