Cardiovascular Systems (NSDQ:CSII) said today it launched its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device in the US and that the first commercial patients have been treated with the device.
The first procedures were performed at the Detroit Medical Center Heart Hospital by Dr. Mahir Elder and at the Arkansas Heart Hospital by Dr. Ian Cawich and Dr. Vasili Lendel, the St. Paul, Minn.-based company said.
“From a physician’s perspective, radial access is a viable alternative that allows us to minimize bleeding and avoid commonly diseased femoral arteries. Additionally, it allows for both bilateral diagnostics and interventions while also eliminating the need for femoral closure devices. The result for patients is a far less invasive procedure,” Dr. Cawich said in prepared remarks.
“Radial access has been on the rise for percutaneous coronary interventions for several years, and the benefits have been well documented. Now, I’m excited that new devices like CSI’s Extended Length OAS are enabling me to bring the benefits of radial access to another patient population in those undergoing peripheral vascular interventions,” Dr. Lendel said in a prepared statement.
Cardiovascular Systems said it is hopeful for a full commercial device during its fiscal year 2019.
“The first procedures using the extended length Diamondback 360 OAD is a milestone for physicians, patients, and our company. When surgery is necessary, PAD lesions can be treated through femoral artery access. However, factors such as obesity, the presence of vascular disease and scar tissue can complicate femoral access. Radial access allows physicians to reach and treat lower limb PAD lesions through the radial artery in the wrist, providing an alternative access point and more options to treat complicated and at-risk patients. CSI is committed to innovation and cultivating less invasive access sites for percutaneous interventions. Our extended length Diamondback 360 OAD demonstrates that commitment and reflects the hard work of our team on behalf of patients and physicians,” prez & CEO Scott Ward said in a press release.
Last week, Cardiovascular Systems saw shares fall after the medical device maker posted growing losses, despite having topped loss-per-share consensus on Wall Street with its second quarter earnings results.
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