China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced that its subsidiary, Shanghai Angiocare Medical Technology Co., Ltd, has received market approval from the National Medical Products Administration (NMPA) for its multipole renal arterial radiofrequency ablation system, Iberis. The device is approved as an adjuvant therapy for refractory hypertension and hypertension patients with drug intolerance.
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The Iberis system, which includes a disposable multipole renal artery radiofrequency ablation catheter and a renal artery radiofrequency ablation device, received approval based on results from the pivotal Iberis-HTN study. In this study, the treatment group met the primary clinical endpoint of therapeutic effect, showing significant improvement in average systolic blood pressure during 24-hour dynamic monitoring six months post-surgery compared to baseline. This outcome was notably better than the sham surgery group.-Fineline Info & Tech
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