4:00PM
CIMIT Strategic
Project Award Announcement
John
A. Parrish, MD, Director of
CIMIT, japarrish@partners.org
4:15PM CIMIT Forum: Cardiac Device Development
Forum Moderator: James E. Muller,
MD, CEO, InfraReDx, Inc, jmuller@infraredx.com
Convergence in Health Care
Technology: Devices, Biologics, Pharma, IT, Communications and Imaging
Stephen N. Oesterle, MD, Senior Vice President, Medicine &
Technology, Medtronic, Inc., stephen.n.oesterle@medtronic.com
Medtronic is one of the world’s largest
producers of biomedical devices, employing 40,000 people worldwide and annually
generating around $13 billion in revenue.
The company offers products to treat a broad range of chronic
degenerative diseases; and every year, the company spends about $1.5 billion on
research and development. To continue
its success, the company recognizes that it must adapt with the changing face
of modern medicine. Medtronic is
thinking about several medical trends that will most likely occur over the next
decades. As the
The medical
industry seems to be entering a new era.
In the first half of the twentieth century, medical therapies were often
based on the extirpation of diseased tissue or organs. More recently, therapies have depended upon
the implantation of tissue, mechanical devices, or even organs. With the medical community’s growing
understanding of the human genome, these palliative techniques may soon be
obsolete. It appears to be a “central
dogma of biotechnology” that all diseases can be reduced to protein imbalances,
and many different therapies, from mRNA suppression to gene therapy, are being
developed to treat these protein imbalances.
Medical devices will play a major role in this new medical age because
molecular therapies will be most effective only if they are combined with
site-specific delivery platforms.
Implantable physiologic sensors are also poised to become valuable
medical tools, and in the not-so-distant future, small implanted devices may
allow physicians to monitor a patient’s condition remotely via information
transmitted over existing communications networks. In this new age, medicine will increasingly
involve the integration of the physical, life, and information sciences.
Challenges in Cardiac Device Development
Donald S. Baim, MD, Executive Vice President, Chief Medical
and Scientific Officer,
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
Panel
discussion