When a device meets its primary endpoint in a first-in-human clinical trial, it's generally regarded as a good thing. But when a device performs even better than expected, it's very good. And when the device in question is a first of its kind, such results are even more remarkable.

Patients who suffer from wet age-related macular degeneration (AMD), a leading cause of permanent vision loss, typically have to receive several anti-vascular endothelial growth (anti-VEGF) injections a year to maintain vision. This method of treating wet AMD is not only inconvenient for patients but places a considerable cost burden on the healthcare system. One company that has been working to offer a less invasive, less expensive alternative for wet AMD treatment, says it is currently preparing for commercial expansion in Europe.

With a series of clinical trials under its belt already, Medtronic (Minneapolis) continues to lead the way for renal denervation as a means to significantly reduce blood pressure in patients with treatment-resistant hypertension. Last week the company released three-year results from its SYMPLICITY HTN-2 trial at TCT in San Francisco. This week the company followed that up with FDA approval of an investigational device exemption (IDE) for SYMPLICITY HTN-4, the first randomized trial to investigate renal denervation for the treatment of moderate uncontrolled hypertension in U.S. patients.

Neovasc (Vancouver, British Columbia) reported top-line results for its COSIRA (Coronary Sinus Reducer for treatment of Refractory Angina) trial assessing the efficacy and safety of the Neovasc Reducer, a new percutaneous device for the treatment of refractory angina. The data shows that the Reducer achieved its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina.

Last week a number of companies working in the transcatheter aortic valve implantation/replacement (TAVI/TAVR) space presented data at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. While the big hitters in the space shared the bulk of the TAVI spotlight at TCT, namely Medtronic (Minneapolis) and Edwards Lifesciences (Irvine, California), there was also well-deserved enthusiasm for some of the smaller players, like Direct Flow Medical (Santa Rosa, California).

Gaining regulatory approval for a new device in the U.S. is rarely an easy or short process, but for some medical device companies that journey is a heck of a lot longer than anticipated. One company that is all too aware of how difficult the FDA approval process can be is FzioMed (San Luis Obispo, California), which has been trying to get FDA approval for its Oxiplex Gel for 12 years. The company reported this week that the FDA has approved its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel to be used during lumbar spine surgery.