Good news for dialysis patients! Medtronic new paclitaxel drug coating equipment approved by FDA

Recently, Medtronic's new drug coated balloon in.pactav has been approved by the US FDA The balloon is specially designed by Medtronic to help clear the venous access used by dialysis patients It is understood that in.pactav pactav paclitaxel coated airbags will be targeted at the U.S market and will be available in different sizes for patients compared with another similar Amiral airbag catheter of the company In Pactav has previously obtained CE mark for patients with end-stage renal disease to help them reopen collapsed arteriovenous fistulas A spokesman for Medtronic previously said that the company had no plans to replace the original equipment with in.pact Fistulas are surgical bridges that direct blood from the arteries to the veins in the arms to help the blood vessels withstand the pressures involved in regular hemodialysis However, these vessels will continue to narrow over time, requiring patients to perform the necessary maintenance procedures throughout the year, which may disrupt critical treatment Mark pacyna, vice president and general manager of Medtronic's peripheral vascular business, said: "FDA's approval of in.pactav drug coating balloon marks an important step forward for paclitaxel coating equipment More importantly, this product enables us to extend the proven in Pact drug coated balloon platform beyond the superficial femoral artery " This approval is based on data from a randomized clinical in.pactavaccesside study submitted in September to evaluate in.pact Gamma The safety and effectiveness of drug coated balloon and percutaneous transluminal angioplasty in the treatment of primary or restenosis obstructive lesions of upper extremity autogenous AV fistula The follow-up time was 24 months, using 1:1 randomized control The study involved 330 patients from 30 medical centers in the United States, Japan and New Zealand After 180 days, 86.1% of the target vessels in the in.pact group remained open, compared with 68.9% of the patients who received traditional percutaneous transluminal angioplasty The data also showed that there was no significant difference in mortality between the in Pact group and the control group within 12 months Professor Robert Lookstein, the lead researcher of the study in the United States, said: "pactav pactav pactav pactav coated air bag was finally approved with positive clinical evidence At the same time, this technology can also reduce repeated intervention by 56%, which can bring significant clinical benefits to patients This is great good news for patients undergoing hemodialysis and in urgent need of treatment " Reference source: fdaapprovesmedtronic's split axle balloon for clearing dialysisfistulas this article is the reprinted content of yaozhi.com, the copyright belongs to the original author, the purpose of reprinting is to transmit more information, does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.