Transcatheter deep venous arterialization system for CLTI gains FDA approval
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Key takeaways:
- The FDA approved a transcatheter deep venous arterialization system for treatment of chronic limb-threatening ischemia (CLTI).
- The system can treat patients with CLTI who cannot have revascularization.
LimFlow announced that its transcatheter deep venous arterialization system for treatment of chronic limb-threatening ischemia was approved by the FDA.
The LimFlow system for transcatheter arterialization of deep veins (TADV) diverts arterial flow from the tibial artery to the tibial veins and has been shown to be effective in patients with so-called “no option” chronic limb-threatening ischemia (CLTI), meaning they are not candidates for surgical or endovascular revascularization, according to a press release from the company.
“Candidates for this treatment are patients with CLTI who do not have standard options for improving the arterial flow into the foot,” Daniel G. Clair, MD, professor and chair of the department of vascular surgery and section of surgical sciences at Vanderbilt University Medical Center, told Healio. “These might be patients whose arteries in the foot are so diseased that flow cannot be restored to the foot arteries. It might be patients who don’t have a bypass option or angioplasty or stent option to improve the blood flow to the foot. TADV with the LimFlow system diverts arterial flow in the leg into the veins of the calf and directs this flow into one of the veins of the foot to use the veins as a method to get oxygenated blood into the circulation of the foot.”
Approval was based in part on the results of the PROMISE II trial, in which, as Healio previously reported, 66% of patients with no-option CLTI and Rutherford class 5 or 6 achieved amputation-free survival at 6 months, beating the performance goal of 54% based on prior literature. At 6 months, the rate of limb salvage was 76% and the rate of overall survival was 87%.
“There are a number of patients who do not have standard options available for restoring blood flow to the foot. This is the first time a therapy has proved beneficial in reducing the likelihood of amputation for these patients,” Clair, who is co-principal investigator of the PROMISE II and III trials, told Healio. “This offers the opportunity to keep their limb, and maintain their ambulatory status and independence. The [PROMISE II trial] has shown that this procedure can be disseminated effectively and should continue to improve the chances for patients with CLTI to progress to healing and limb salvage.”
The FDA had previously granted the system a breakthrough device designation, which expedites the development and review of devices intended to treat a serious condition where preliminary clinical evidence indicates potentially substantial improvement over available devices.
For more information:
Daniel G. Clair, MD, can be reached at dan.clair@vumc.org.
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