The CIMIT Forum held on Feb. 5 at the Simches Research Center focused on the topic of “Cardiac Device Development,” and featured two lively presentations about the science and business of caring for those with heart disease.

Presenting were Stephen N. Oesterle, MD, senior vice president, medicine and technology, at Medtronic Inc.; and Donald S. Baim, MD, executive vice president and scientific officer, Boston Scientific Corp. Moderating was James E. Muller, MD, who is CEO of InfraReDx, Inc.

Dr. Oesterle’s topic was “Convergence in Health Care Technology: Devices, Biologics, Pharma, IT, Communications and Imaging.” He suggested that the era of implanted electro-mechanical devices is disappearing. Dr. Oesterle said that therapeutic proteins, cell therapies, interference RNA and gene manipulation – known as “biologics” – offer a realistic approach to restoration and cure for many of the same degenerative and chronic diseases that have been the focus of device therapy.

He said that in coming years, aging Americans will comprise a “locust swarm” that will be seeking new and minimally invasive ways to treat chronic problems.

Dr. Oesterle, who once was with CIMIT, said that “combination devices” – biologics delivered by devices such as catheters and pumps – will define many therapies in the next decade.

Dr. Baim, also once with CIMIT, spoke on “Challenges in Cardiac Device Development.” He noted that cardiovascular devices such as stents have revolutionized the treatment of coronary artery disease over the past 30 years. He said that the large number of procedures (1 million per year) and associated revenues ($8 billion per year) have fueled the development of the stent industry.

But Dr. Baim stated that studies challenging the efficacy of some drug-eluting stents over the last 18 months have caused a 20 percent drop in the use of such devices. He indicated that it will be difficult for the large medical device companies to regain their momentum, due to increased regulations from the Food and Drug Administration and added competition from new companies.

The history of cardiac devices is one of iterative improvement.  When Gruentzig performed the first balloon angioplasty, the procedure was crude and did not have a great success rate; but over time, serial improvements made it into a widely used method of coronary revascularization.  Over the last two decades, stents have emerged as another means of treating stenotic arteries.  While stents have improved patient outcomes, they have also led to new complications, such as restenosis and stent thrombosis.  Drug-eluting stents were developed to prevent restenosis, but in 2006, a few studies were published suggesting that drug-eluting stents led to higher risks of death than bare-metal stents.  The use of drug-eluting stents decreased.  Further investigation and data analysis, however, revealed that the results of the original studies were skewed by confounding factors such as the fact that drug-eluting stents were disproportionately used in patients with diabetes and other background risks.  Second- and third-generation drug-eluting stents are being developed, and these stents seem to pose the same mortality risks as bare-metal stents. 

There are many financial advantages and disadvantages to manufacturing cardiac devices.  The advantages include the fact that heart disease is the leading cause of death in the U.S. and the fact that the problem is well suited to mechanical intervention.  Disadvantages include the fact that it takes a lot of time for a new device to be approved for use in people and the fact that the industry is becoming increasingly competitive. 

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