Excerpted from “Outlook for the healthcare industry in 2012”
The year 2012 might see the much-hyped therapies of stem cells and gene therapy become clinical realities. Data showing that heart-derived stem cells improved the cardiac output of heart failure patients with myocardial infarction seemed to be a true breakthrough. Likewise, the cure (for the time being) of six hemophiliac patients using viral-vector gene therapy was also a clinical breakthrough.
Some of the most promising and innovative new medical devices to track in 2012:
- Renal artery ablation to treat hypertension: Medtronic (MDT) is in the lead with this technology and others are following. If this technique is safe, it promises to compete with multibillion-dollar drugs.
- Bioabsorbable coronary stents: This technology will not be approved in 2012, but any clinical trial news will be significant given the paradigm changing potential of these devices.
- Next-generation catheter-delivered aortic valves: The currently approved first-generation Edwards Lifesciences (EW) Sapien valve is not ready for mainstream use beyond the surgically ineligible patients. In addition, Medicare might restrict coverage of these first-generation devices. However, smaller devices, coupled with embolic filters to reduce stroke rates, might achieve broader use. Monitor any trial data of the combined use of embolic filters and the valves.
- Wireless Pulmonary Artery Pressure Senor: The CardioMEMS (with investments from St Jude Medical (STJ)) was rejected by an FDA advisory committee. However, this device will likely be considered an “innovative” device as part of the new fast-track program of the FDA’s CDRH. Do not be surprised to see it approved.
- Troubled devices: As described throughout this report, the medical devices that are the current main revenue products for most companies will be under pressure in 2012. They include orthopedic hip and knee implants, spine fusion hardware and growth factors, ICDs, stents, etc.