Cardiac Device Development

What a great forum week!

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

The medical device industry remains a vibrant participant in the delivery of health care in the 21st century, but will necessarily evolve to incorporate the myriad important advances in biologics, information, imaging and communication technologies and systems. Medical devices have largely been used as palliative instruments. Implanted electro-mechanical devices have been designed to alleviate the symptoms of chronic and degenerative diseases.  Therapeutic proteins, cell therapies, interference RNA and gene manipulation fall within the rubric of “biologics” and 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. In contrast to small molecules, biologics cannot be ingested. They require targeted and controlled delivery. Combination devices—biologics delivered by devices such as catheters and pumps--will define many therapies in the next decade.

Information and communication technology will be catalyzed with devices.  Implanted sensors will communicate not only in closed loop systems with devices but externally with hand held communication sets that will allow physicians to remotely monitor and control the care of patients with chronic diseases such as heart failure, diabetes and hypertension. Pre-operative and intra-operative imaging will accelerate less and less invasive diagnosis and treatment for cardiac, orthopaedic and neurological intervention with medical devices.

Challenges in Cardiac Device Development
Donald S. Baim, MD, Executive Vice President, Chief Medical and Scientific Officer, Boston Scientific, donald.baim@bsci.com

Cardiovascular Devices have revolutionized the treatment of coronary artery disease over the past 30 years. Device development, including the introduction of newer modalities such as stents, atherectomy, and now drug-eluting stents, have made progressive improvements in procedure applicability (now 3/4 of all revascularization), procedure success (now 98%), procedure safety (now <1% major complications), and durability (freedom from restenosis now >95%). The large number of procedures (> 1 million/year) and associated revenues (>$ 8 billion) have fueled this development.

Against these impressive gains, the challenges to drug-eluting stent safety and appropriate procedure use (versus medical, surgical, or bare metal stents) over the last 18 months have for the first time caused a 5% contraction in the PCI market, and a 20% drop in DES use. At the same time, FDA requirements have increased the size, complexity, and cost of clinical trials for new devices. Even as this contracted market starts to recover, it is being divided among new competitors, and faced with greater regulatory burdens (after this year, there will be probably be no new DES until 2012) challenging the ability to continue the pace of progress.

Panel Discussion Video

Comments

[Laurie, CIMIT Webmaster]

Hi Susan - It's our pleasure. :)

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Laurie, CIMIT Webmaster

[Susan]

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Susan

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