Foldax is targeting India for the first approval of its polymer mitral surgical heart valve. The Salt Lake City, UT-based company spoke with MD+DI regarding its regulatory plans after reporting positive 30-day results from a prospective, multicenter, single-arm, clinical study of the Tria mitral surgical heart valve with LifePolymer conducted in India at the New York Valves: The Structural Heart Summit 2024.“Our first regulatory approval will be in India,” Ken Charhut, Foldax CEO told MD+DI.

Foldax针对印度首次批准其聚合物二尖瓣手术心脏瓣膜。这家总部位于犹他州盐湖城的公司与MD+DI就其监管计划进行了对话，此前该公司在印度纽约瓣膜：2024年结构性心脏峰会上报告了一项为期30天的前瞻性，多中心，单臂临床研究结果，该研究在印度进行。Foldax首席执行官Ken Charhut告诉MD+DI：“我们的第一个监管批准将在印度。”。

“We expect that to happen later this year. One of the reasons we picked India is because it has a very high incidence of rheumatic heart disease. Rheumatic heart disease patients tend to be younger. You get it as a child and if it gets untreated some years later … your mitral valve begins to kind of disintegrate.

“我们预计这种情况会在今年晚些时候发生。我们选择印度的原因之一是它的风湿性心脏病发病率很高。风湿性心脏病患者往往更年轻。你从小就患有风湿性心脏病，如果几年后得不到治疗……你的二尖瓣开始崩解。

Most importantly this could happen with young women.”The Tria mitral surgical valve study enrolled 67 patients ranging from 19 to 67 years of age at eight sites across India. The device stands out because of the LifePolymer component.“The LifePolymer material is uniquely formulated for heart valves and has been shown in animal studies to resist calcification, which can lead to stiffening leaflets that restrict blood flow through the valve,” said Isaac George, MD, Surgical Director of the Heart Valve Center at Columbia University in a release.

最重要的是，这可能发生在年轻女性身上。”Tria二尖瓣手术研究在印度的八个地点招募了67名年龄在19至67岁之间的患者。该设备因其LifePolymer组件而脱颖而出。哥伦比亚大学心脏瓣膜中心外科主任艾萨克·乔治（IsaacGeorge）医学博士在一份新闻稿中说：“生命聚合物材料是为心脏瓣膜独特配制的，在动物研究中已经证明它可以抵抗钙化，钙化会导致小叶变硬，从而限制血流通过瓣膜。”。

“Now, in the India study, imaging of the Tria mitral surgical valve in humans at 30 days shows no sign of calcifying or deteriorating leaflets. A durable non-animal tissue heart valve that may not require long-term anti-blood clotting medication could be transformative in providing new options for patients suffering from mitral valve disease,” he said.Related:Foldax Presses Through COVID-19 with Trial ExpansionCharhut said the study is.

“现在，在印度的研究中，人类在30天时对Tria二尖瓣手术瓣膜的成像显示没有钙化或恶化的迹象。一种不需要长期抗凝血药物的耐用非动物组织心脏瓣膜可能会为二尖瓣疾病患者提供新的选择，”他说。相关报道：Foldax通过新型冠状病毒肺炎（COVID-19）进行试验扩展，Harhut说这项研究是。