Business Wire03.06.18
Cardiovascular Systems Inc., a medical device company developing and commercializing interventional treatment systems for peripheral and coronary artery disease, announced that the first patients were treated using its U.S. Food and Drug Administration (FDA)-cleared extended length Diamondback 360 Peripheral Orbital Atherectomy Device (OAD) to treat peripheral artery disease (PAD). Dr. Mahir Elder, an interventional cardiologist at the Detroit Medical Center Heart Hospital (Michigan), and Drs. Ian Cawich and Vasili Lendel, both interventional cardiologists at Arkansas Heart Hospital, treated patients using the new device.
Cawich noted, “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.”
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 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.”
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:
“As an interventional cardiologist, 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,” Elder said.
The radial access Diamondback 360 OAD, currently available via a limited market rollout, features a 5 Fr profile and three crown sizes:
“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," said Scott Ward, CSI chairman, president, and CEO. "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 anticipates a full commercial launch of the device in its fiscal year 2019.
As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates. Literature shows that balloon angioplasty and stents can have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results. Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems, which are minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences.
Cardiovascular Systems Inc., based in St. Paul, Minn., is developing and commercializing solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 356,000 of CSI’s devices have been sold to leading institutions across the United States.
Cawich noted, “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.”
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 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.”
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, 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,” Elder said.
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 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," said Scott Ward, CSI chairman, president, and CEO. "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 anticipates a full commercial launch of the device in its fiscal year 2019.
As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates. Literature shows that balloon angioplasty and stents can have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results. Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems, which are minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences.
Cardiovascular Systems Inc., based in St. Paul, Minn., is developing and commercializing solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The FDA granted the first 510(k) clearance for the use of the Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the Coronary Orbital Atherectomy System. To date, over 356,000 of CSI’s devices have been sold to leading institutions across the United States.