Caritas St. Elizabeth's Medical Center
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In the interventional cardiology community, 2010 could certainly be considered a breakthrough year for percutaneous heart valve devices. At two major US cardiology conferences: the American College of Cardiology in the spring, and most recently, the Transcatheter Cardiovascular Therapeutics symposium, held in September, impressive results from randomized trials of transcatheter heart valve replacement/repair devices set the venues abuzz and had physicians speculating about possible near-term paradigm shifts in the way heart valve disease will be treated. The big questions now are how long it will take before these devices reach the US market, and exactly how many US patients are likely to be implanted once they are available.
Despite all of the recent advances in diagnostic imaging, the small bowel remains a black box with physicians still unable to directly view the roughly 20-foot length of this portion of the gastrointestinal tract. Small bowel direct imaging is currently limited to the first few feet through a traumatic procedure called push enteroscopy. The result of the small bowel's diagnostic inaccessibility is that many patients with conditions that arise in the small intestines are forced to undergo numerous invasive tests of other parts of the GI tract, none of which may produce conclusive results. Given Imaging has taken a futuristic approach to GI imaging by utilizing advances in a number of disparate fields, including visualization, miniaturization, and chip construction, combined with principles taken from Israeli missile design technology. The company has developed an ingestible, grape-sized capsule that transmits direct images of the entire GI tract--including for the first time the small bowel--as the device travels through and eventually is expelled from the body in a procedure called capsule endoscopy. All this while the patient goes about his or her normal daily routine. Capsule endoscopy represents the first major breakthrough in gastrointestinal diagnostic imaging in nearly 25 years. Given has been on the fast track. Less than four years from its founding, the company has obtained product approvals and done a successful IPO. But its biggest challenge remains: to overcome the inertia from the lack of innovation in GI medicine and convince gastroenterologists to adopt this radical new diagnostic tool.
Genzyme Surgical is intent on making a name for itself in cardiac surgery, and banking on a hybrid strategy to distinguish itself from giant competitors like Medtronic and Guidant. Its plan is to combine traditional surgical instruments, from which it expects to derive most of its near-term growth, with longer-term plays in biomaterials and biotherapeutics, a strategy it calls biosurgery. As a tracking stock of Genzyme Corp., it has the advantage of being able to tap into Genzyme's deep expertise in gene and cell therapies in order to develop therapies for severe heart failure. But as it puts in place a diverse portfolio of expertise, it runs the risk of spreading itself too thin. Moreover, it faces skepticism from Wall Street and criticism that it doesn't have the critical mass to be a player in the fastest growing area of cardiac surgery--minimally invasive beating heart surgery, where it is trying to make inroads. Genzyme Surgical executives say that it is forging a new path in a field rife with tradition and that ultimately it will have more to offer cardiac surgeons than its competitors--moreover, it is not reliant upon the success of any one product.
Ten years ago, researchers observed that injecting vascular endothelial growth factors or fibroblast frowth factors into animal models of ischemia stimulated the formation of new blood vessels. The discovery that, with a bit of prompting, the body's natural capacity for angiogenesis could be accelerated, has drawn more than a dozen drug firms and a handful of cardiovascular device companies into the search for a biological alternative that can aid or replace current cardiovascular interventions, or even delay the progression of heart disease.
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