Finally, in 2008, the Food and Drug Administration cleared the device for finding lipid-core plaques in the coronary arteries. 最终，2008年，美国食品和药品管理局(Food and Drug Administration)称该设备可以找出冠状动脉中的脂质核斑块。
Cardiologists and hospitals were unimpressed. 'They said, 'Yes, you can find these plaques, but so what?' ' Dr. Muller says. ' 'What's the clinical benefit of finding them?' It was an appropriate question, and we didn't have the data.' 心脏病学家和医院不为所动。穆勒博士说，“他们说：”是的，你能找到这些斑块，但那又怎么样?找到他们有什么临床意义?'这是个切中要害的问题，而我们没有相关数据。“
Prospects Brighten 前景光明
So the next critical task for the company is proving in clinical trials that plaques identified by the device are associated with heart-attack risk, and that 'treating' them reduces risk. 因此，该公司的下一个重要任务是在临床实验中证明该设备识别出的斑块与心脏病发作风险相关，且“治疗”它们可以降低发病风险。
Success isn't assured. Just last month, researchers led by Armin Arbab-Zadeh of Johns Hopkins University School of Medicine in Baltimore published a comprehensive review of the biology of heart attacks in the journal Circulation, which said that vulnerable plaques often rupture without causing a heart attack and that a 'perfect storm' of other conditions is required before one occurs. 事情并非一帆风顺。就在上个月，巴尔的摩约翰?霍普金斯大学医学院(Johns Hopkins University School of Medicine)的阿明?阿巴卜-扎德(Armin Arbab-Zadeh)领导的研究人员在《循环》(Circulation)杂志上发表了一篇关于心脏病发作的全面生物学综述，该文称，脆弱斑块破裂时往往不会导致心脏病发作，而心脏病发作前，需要一场包含其他一些条件的“完美风暴”。
That complicates efforts to predict which patients are vulnerable to heart attacks, the researchers said, adding: 'Intervening exclusively on single, potentially vulnerable plaques is unlikely to reduce the incidence of acute coronary events.' 研究人员称，这让预测哪些病人易发作心脏病的努力更加复杂，他们还说，“只干预一种易破裂的斑块不太可能降低急性心脏病的发病率。”
Dr. Muller takes issue with some details in the report, and other research convinces him he is on the right track. 穆勒博士不同意该报告中的某些细节，其他研究让他相信，他走的是一条正确的路。
Even if the trials succeed, another concern is that because the device is threaded into the heart, it carries its own risk for complications as an invasive procedure. It isn't desirable to cause a heart attack in the name of trying to prevent one. 即使实验成功，也还有另一种担心，因为该设备将穿入心脏，所以鉴于侵入式治疗的复杂性其本身也有风险。出发点是要预防心脏病，结果却引发了心脏病，这可不是为人所乐见的。
To avoid that issue, Dr. Muller envisions the technology as part of a strategy in which people would first be identified as at risk through a genetic test and a noninvasive imaging test such as a CT scan before being referred for the spectroscopy analysis. 为了避免这个问题，穆勒博士将这项技术设想为以下策略的一部分：首先通过基因检测和CT扫描等非侵入式成像检测识别出有心脏病风险的人群，然后再对他们进行光谱分析。
Despite these challenges, the device's prospects have recently brightened, Dr. Muller says. Last year, researchers published a study suggesting the device could help prevent small heart attacks that occasionally occur in about 10% of procedures when stents are deployed to prop open diseased coronary arteries. 穆勒博士说，尽管有这些挑战，但该设备的前景最近变得更加光明。去年，研究人员发表的一项研究称，该设备有助于预防轻度心脏病发作，在扩张病变冠状动脉的支架植入手术中，这种情况的发生几率约为10%.
The study found that such heart attacks occurred in 50% of cases when the stent was implanted directly over a cholesterol-rich plaque, compared with 4% involving stable plaque. 该项研究发现，当支架直接植入高胆固醇斑块时，发生这种心脏病的机率为50%，而植入稳定斑块时，发生这种心脏病的机率仅有4%.
By knowing in advance if they were stenting a hot plaque, doctors could recommend other options such as bypass surgery or drug treatment, Dr. Muller says. 穆勒博士说，如果医生们在危险斑块上放置支架前预先了解这一信息，那么他们就可以推荐采取其他措施，例如心脏搭桥手术或药物治疗。
Some are skeptical. Kirk Garratt, cardiologist at Lenox Hill Hospital in New York, says heart attacks are too rare among stent patients to justify the added cost of a routine spectroscopy test. 有些人对此表示怀疑。纽约勒诺克斯山医院(Lenox Hill Hospital)的心脏病医生柯克?加勒特(Kirk Garratt)称，接受支架手术的病人中心脏病发作的病例非常少，无法证明增加常规光谱检测这项费用的合理性。
But Dr. Muller says interest in the idea is growing. Revenue in the first quarter broke all records, and the company is scrambling to meet demand from more than a half-dozen countries. 'The reason we built the company is not the reason we're being used,' he says. 'But we're getting traction.' 但穆勒博士说，人们对该想法的兴趣正在增加。该公司今年第一季度的收入打破了历史纪录，并正力争满足七、八个国家的需求。他说，“我们现在被顾客青睐的原因与我们当初创建这家公司的初衷并不相同。但我们正在得到人们的注意。”
He likens realizing the broader goal to climbing Mount Everest. 'We're currently at base camp,' he says. 他将实现更广阔的目标比作攀登珠穆朗玛峰。他说，“现在我们还在大本营。”