Cardiovascular Systems, a medical device manufacturer based in St. Paul, Minnesota, announced Tuesday that enrollment for its Diamondback 360 Orbital atherectomy device trial has ended. The new Diamondback 360 system is designed to quickly and easily clear calcium deposits from a patient’s coronary arteries. The company reported that it has successfully enrolled 443 patients in its Orbit II trial.
The Diamondback 360 is a catheter-delivered cardiovascular device that uses a specialized crown to remove deposits and other blockages from a patient’s constricted blood vessels. The specialized crown in the system is made from diamonds for strength and durability. In a press release, Cardiovascular Systems stated that its Orbit II trial would back the company’s premarket application with the FDA.
Cardiovascular Systems manufactures a variety of medical devices to improve cardiovascular health. According to the company, an estimated 17 million people currently suffer from peripheral artery disease (PAD). Since PAD increases a patient’s risk obesity, diabetes, renal insufficiency and hypertension, it’s important for patients to receive treatment for this issue as quickly as possible.
In prepared remarks, CEO and president David Martin said, "Completing Orbit II enrollment is a significant milestone in our efforts to secure a coronary indication to treat arterial calcium – a vastly underestimated problem in medicine today,"