Renal denervation is arguably the hottest new device technology to come along in years, with applications in a variety of chronic diseases including hypertension and diabetes, to name just two. Yet just over a decade ago, most people laughed off the concept, and they might still be laughing were it not for the efforts of a novel device development company called Coridea.
Beaten down by the great recession, the large joint arthroplasty market appears to be on the cusp of a turnaround, with several big players reporting encouraging Q4 and full-year 2012 results. A full recovery in this space is likely to take some time, but technology advances could help jumpstart the process, and there may be some interesting dynamics ahead in the patient-specific implant and robotic ortho device arenas.
Although many companies have fallen short in developing a truly effective minimally invasive device for the treatment of chronic GERD, Torax Medical’s co-founder, president, and CEO Todd Berg believes the company’s new Linx Reflux Management System will find success because it is fundamentally unlike anything else that has come before. In an interview with Medtech Insight, Berg discussed the Linx device, the GERD market, and the company’s strategies for success.
The agency called an advisory committee meeting and public comment period to collect feedback from device firms and others on effects that extreme weather and natural disasters pose to medical device safety and quality.
Latin America’s 30-year transition toward urbanization and economic growth has opened up a huge opportunity for medical device companies to provide treatment solutions for the “diseases of affluence” that are now common in the region. Device imports into Latin America totaled nearly $8 billion in 2009 and import growth is expected to remain strong going forward, particularly in Brazil and Mexico. The outlook is particularly positive for the heart and vascular disease markets.
Certain medtech companies might benefit from looking to the California HealthCare Foundation (CHCF) as a new funding source that will help get them ready for venture funding or expansion into new markets. The CHCF Health Innovation Fund is authorized to provide up to $3 million (with most deals falling in the $250,000 to $1 million range) in debt or convertible equity to health care companies that meet the private non-profit foundation’s goals of increasing access to care for low-income patients or reducing costs.
Several new modalities are poised to change the way breast cancer screenings and diagnostics are performed as physicians and patients continue to search for technologies that can do more than standard X-rays. Ultrasound, computed tomography, and 3-D imaging are being touted as ways to improve the detection of tumors – especially in women with dense breast tissue – as well as to reduce exposure to radiation. Currently, the market is dominated by large, established manufacturers, but some new players are bringing in innovative options that are poised to push the field forward.
With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.
Brief summaries of recent medtech market and industry developments. This month we cover China’s switch to a centralized billing system, St. Jude Medical’s RESPECT PFO closure trial, FDA’s approval of HeartWare’s LVAD, and end-of-the-year medtech M&A.
In less than a month, the US Food and Drug Administration (FDA) recently approved three spine PMAs, two for cervical disc replacement devices, and there are two more cervical discs in the queue for near-term PMA approval. All of this activity suggests the $122 million US cervical disc market is about to gear up.
