11.01.11
Medtronic Inc. has received the nod from the U.S. Food and Drug Administration approval for another kind of stent system for the treatment of peripheral artery disease. The agency approved the Minneapolis, Minn.-based firm's Assurant Cobalt Iliac Balloon-Expandable Stent System.
The regulatory victory for Medtronic’s Cardiac and Vascular Group comes a week after an FDA panel recommended against the approval of one of its cardiac ablation systems for atrial fibrillation.
Leveraging the strength of cobalt chromium with a thin, round, edgeless design gives the new stent optimal conformability to the wall of the vessel and allows for smooth delivery to iliac artery lesions, the company said in a statement. It complements Medtronic’s self-expanding Complete SE Vascular Stent, which was FDA approved in March 2010.
“By offering two stents for the treatment of narrowed iliac arteries, interventionalists who treat peripheral vascular disease now have more options to address their patients’ various clinical needs,” said Medtronic spokesman Joe McGrath.
Stents have been a source of growth for Medtronic recently. According to the company’s first-quarter earnings statement in August, revenue for Medtronic’s Endovascular & Peripheral business grew 16 percent, driven by the launch in the United States of the Endurant stent graft for abdominal aortic aneurysms and the availability of drug-eluding balloon stents in international markets.
An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration.
In an 8-2 vote members of the agency's Circulatory System Devices Panel said that the risks of the device outweighed its benefits.
All catheter ablation for AF other than paroxysmal is off-label. The panel, in a way, sent a signal to electrophysiologists that they should continue using other devices off label.
The panel's chairman, Clyde Yancy, holding out hope for eventual approval of the device told Medronic representatives: ”I hope what you heard today is not a no, but a not yet.”
In other regulatory news, the FDA did OK an Investigational Device Exemption (IDE) for Medtronic to conduct a pivotal in-home clinical trial protocol for the ASPIRE study of the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation.
FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for Type 1 diabetes management. This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic’s newest continuous glucose sensor, the Enlite sensor, will be tested as part of the overall system.
ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF in the actual use environment and by the intended use population with Type 1 diabetes.
The regulatory victory for Medtronic’s Cardiac and Vascular Group comes a week after an FDA panel recommended against the approval of one of its cardiac ablation systems for atrial fibrillation.
“By offering two stents for the treatment of narrowed iliac arteries, interventionalists who treat peripheral vascular disease now have more options to address their patients’ various clinical needs,” said Medtronic spokesman Joe McGrath.
Stents have been a source of growth for Medtronic recently. According to the company’s first-quarter earnings statement in August, revenue for Medtronic’s Endovascular & Peripheral business grew 16 percent, driven by the launch in the United States of the Endurant stent graft for abdominal aortic aneurysms and the availability of drug-eluding balloon stents in international markets.
An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration.
In an 8-2 vote members of the agency's Circulatory System Devices Panel said that the risks of the device outweighed its benefits.
All catheter ablation for AF other than paroxysmal is off-label. The panel, in a way, sent a signal to electrophysiologists that they should continue using other devices off label.
The panel's chairman, Clyde Yancy, holding out hope for eventual approval of the device told Medronic representatives: ”I hope what you heard today is not a no, but a not yet.”
In other regulatory news, the FDA did OK an Investigational Device Exemption (IDE) for Medtronic to conduct a pivotal in-home clinical trial protocol for the ASPIRE study of the MiniMed Paradigm System featuring Low Glucose Suspend (LGS) automation.
FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for Type 1 diabetes management. This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic’s newest continuous glucose sensor, the Enlite sensor, will be tested as part of the overall system.
ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF in the actual use environment and by the intended use population with Type 1 diabetes.