SUZHOU, China, Feb. 23, 2022 /PRNewswire/ -- SyMap Medical Ltd. (Suzhou, China) announced successful completion of enrollment in the company's SMART Study (Sympathetic Mapping/Ablation Renal nerves for Treatment of hypertension Trial; NCT02761811), using the SyMapCath I™ Catheter/SYMPIONEER S1™ Mapping/RF System for the treatment of uncontrolled hypertension. This is the first pivotal study for registration purpose, worldwide, using targeted renal denervation (RDN) technology to treat uncontrolled hypertension. The system is based on SyMap's proprietary technology with worldwide intellectual property, is the winner of US CRT 2012 Best Innovation Award, and rewardee of China regulatory authority NMAP "Green Channel" designation for innovative medical devices. The system is able to map renal nerves and provide real time feedback before, during, and after RDN procedure in order to achieve selective ablation of renal sympathetic nerves. The completion of enrollment is a major milestone in bringing SyMap's renal nerve mapping/selective ablation system to clinical practice for treatment of uncontrolled hypertension and makes SyMap an undisputable leader in this important emerging field.
The SMART Study is a prospective, multicenter, single-blind, randomized, and sham-controlled trial to evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ and SymPioneer ® TM in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy however, their blood pressure still cannot be controlled. The study enrolled a total of 220 patients at 16 prestigious hospitals in China with dual primary endpoints: the control rate of office systolic blood pressure at 6 months (SBP<140 mmHg); the change in composite index based on the classes and doses of antihypertensive drugs to reach the control of office systolic blood pressure (<140 mmHg) at 6 months.
Using "composite drug index" of antihypertensive medications as one primary clinical endpoint, SMART Study will provide answers to a very important question: whether patients may take less or no antihypertensive drugs after RDN. The innovative concept of drug composite index has been recently validated by the endorsement of Medtronic's SPYRAL HTN study investigators and use of medication index in SPYRAL HTN ON-MED study (Kandzari DE et al: EuroIntervention 2021; 16(18): e1496-e1502).
In order to eliminate drug compliance as a crucial confounding factor interferes with the effects of RDN on blood pressure, a rigorous, standardized antihypertensive drug regimen has been executed during the study: classes, doses, manufacturers and methods to adjust the drugs are restricted per the regimen. LC-MS/MS was utilized to monitor drug compliance throughout the study. Office blood pressure was examined and stored in a specially custom designed system.
This study is co-managed by TigerMed, a leading clinical CRO, and SyMap's clinical team.
The leading principal investigators of SMART Study are Professor HUO Yong at Peking University First Hospital, Professor SUN Ningling/a renowned hypertension specialist, at Peking University People's Hospital and Professor GE Junbo at Shanghai Zhongshan Hospital of Fudan University. Numerous leading cardiologists participated in the SMART study.
SyMap is an innovative medical device company focusing on developing revolutionary device therapies for the unmet clinical needs of major cardiovascular and pulmonary diseases including hypertension, heart failure, arrhythmia, asthma and early-stage lung cancer. Last December, the company announced its latest financing round of nearly $100 million led by Primavera Capital and VMS Group, with the participation of existing investors Sequoia Capital China and Simiao Equity Investment.
The company, co-founded by Dr. Jie Wang and Mr. Kewen Jin, is based in bioBAY, Suzhou, China. Dr. Wang has a long track record in academic research and entrepreneurship. He is a faculty member of the College of Physicians & Surgeons of Columbia University, professor at the Jiangsu Province Hospital and is the former Dean of Medical School, Nanjing University. He has participated in the development of RDN since the technology's infant stages via Ardian Inc.