Cardiovascular Systems, a medical device company developing and commercialising interventional treatment systems for peripheral and coronary artery disease, announced today that the first patients were treated using its FDA-cleared extended length Diamondback 360 peripheral orbital atherectomy device (OAD) to treat peripheral artery disease (PAD). Interventional cardiologists Mahir Elder (Detroit Medical Center Heart Hospital, Detroit, USA), Ian Cawich and Vasili Lendel (both Arkansas Heart Hospital, Little Rock, USA) treated patients using the new device.
Cawich noted, “From a physician’s perspective, radial access is a viable alternative that allows us to minimise 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.”
Scott Ward, Cardiovascular Systems chairman, president and chief executive officer, said “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.”
Lendel added, “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 Cardiovascular Systems’ extended length OAD are enabling me to bring the benefits of radial access to another patient population in those undergoing peripheral vascular interventions.”
As an alternative to femoral access, the extended length Diamondback 360 OAD reduces invasiveness, and often results in greater patient satisfaction. In addition, patients experience:
- Fewer access site bleeding complications;
- The ability to walk less than an hour post-procedure; and
- Shorter hospital stays, on average.
“As an interventional cardiologist”, Elder says, “I value the ability to treat my PAD patients with this device. Treating PAD via radial access enables me to provide a better patient experience that includes faster ambulation and discharge than treating via femoral access.”
The radial access Diamondback 360 OAD, currently available via a limited market rollout, features a 5 Fr profile and three crown sizes: 1.25 diameter solid, 200 cm length; 1.50 diameter solid, 200 cm length; 1.75 diameter solid, 180 cm length.
The company anticipates a full commercial launch of the device in its fiscal year 2019.
Ward concluded, “Cardiovascular Systems 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.”