Tryton Medical: Going Against the Flow in Bifurcated Stents

Article preview reprinted from IN VIVO -  January/February, 2010

IN VIVO -- Many device companies, large and small, have tried unsuccessfully to come up with a stent to treat bifurcated lesions, primarily by focusing on treating the main vessel. Tryton is taking a different approach: using a bare-metal device designed to treat the side branch. The company believes this contrarian strategy pairs perfectly with current drug-eluting stents, making them an ideal acquisition target for a large CV company.  Read more...

Tryton Medical: Going Against the Flow in Bifurcated Stents

Article preview reprinted from IN VIVO -  January/February, 2010

Many device companies, large and small, have tried unsuccessfully to come up with a stent to treat bifurcated lesions, primarily by focusing on the main vessel. Tryton is taking a different approach: using a bare-metal device designed to treat the side branch. The company believes this contrarian strategy pairs perfectly with current drug-eluting stents, making them an ideal acquisition target for a large CV company.

by Stephen Levin

** Bifurcation disease remains one of the largest unmet clinical needs in interventional cardiology, affecting roughly 20% of patients who undergo PCI and comprising a $1.3 billion worldwide market.

** Most of the companies trying to develop a dedicated stent for this market are focusing on treating the main vessel, leaving the side branch either untreated or treated with less than ideal outcomes that may require additional PCI or CABG surgery.

** Tryton Medical is taking a different approach by focusing on the side branch with a stent that can be paired with any other traditional stent in the main vessel.

** The company believes this approach will make it an attractive acquisition candidate for a large cardiology company looking to differentiate its drug-eluting stent business.

Most device innovations are incremental improvements on the status quo that don't significantly change a physician's technique or how a particular procedure is performed. Even major product advances like drug-eluting stents often do not require physicians to substantially alter the way they treat a disease or condition, utilizing basically the same techniques they have traditionally used.

But where incremental improvements in current techniques aren't able to successfully address unmet clinical needs, device innovation often moves to the next level: product solutions that change the way physicians approach and treat a particular clinical problem. Introducing a device that changes physician practice patterns, however, carries increased risk. Getting physicians to adopt a product that requires a new technique or procedure often poses significant clinical and marketing challenges for a start-up that not only has to make the clinical case, but also drive adoption. That risk, however, also presents a potentially significant market opportunity, a powerful incentive for entrepreneurs and investors to try to break new ground. That was the path that Durham, NC-based Tryton Medical Inc. chose to pursue in developing a stent to treat bifurcated coronary disease.

There has been no shortage of attempts by device companies, big and small, to address the problem of bifurcation disease—atherosclerosis at a location in the coronary vasculature where a smaller artery branches off of a main vessel—by developing a stent dedicated to treating lesions at those locations. Those efforts have all failed, largely because they have primarily focused on treating the main vessel, resulting in a variety of awkward, unwieldy products and techniques not well suited to the unique anatomy of bifurcations. These devices have yielded unsatisfactory clinical results, most notably high restenosis rates that often require follow-up treatment, either PCI or in the case of left main disease (a frequent site of bifurcated lesions), CABG surgery.

Tryton founder and chief medical officer Aaron V. Kaplan, MD, himself an interventional cardiologist, recognized that traditional tubular-shaped stents are designed to work best in straight or gently curved vessels, not in the sharply-angled arteries that comprise bifurcations. Indeed, until recently, all traditional stent clinical trials excluded bifurcations. The tortuous anatomy often forces interventionalists to make a difficult choice: either stent the main vessel and ignore the side branch in the hope that the disease there does not hamper flow (an approach known as provisional stenting) or attempt to place stents in both the main and side branches, forcing these devices into an anatomy for which they were not designed.

But give the failures of others, Kaplan chose to go a different route. His idea: since the market already has a number of drug-eluting stents (DES) that are well-suited to treating the main vessel, what really is needed is a device designed specifically to treat the side branch that could be paired with any standard workhorse DES in the main vessel. The result: the Tryton Side Branch Stent System.

One important difference in this approach, however, is that it calls for interventionalists to change the way they currently approach bifurcations. Instead of ignoring the side branch and treating only the main vessel, the Tryton device actually requires the physician to treat the side branch first and then address the main vessel. In Kaplan's view, "Currently there is no easy and reliable way to stent complex bifurcation lesions, so interventionalists have reverted to angioplasty." In his view, "When a dedicated system is available that allows for definitive stenting while preserving the operator's main branch stent choice, interventionalists will adopt it, just as they have adopted stents suited for other lesion categories."

The company's contrarian approach is manifest in another decision Kaplan made: to develop a bare-metal side-branch stent at a time when the whole industry seemed to move toward drug-eluting stents—a move that, in hindsight, looks smart, given the concerns about late stent thrombosis raised a couple of years ago. Tryton's contrarian stance has enabled it to differentiate itself from the host of other companies working on bifurcated stents, making it the only company with a balloon-expandable side-branch device. Now, with its technology earning praise in an early roll-out in Europe, it's up to Tryton's new CEO, former Guidant executive, J. Greg Davis, to prove that that contrarian approach will quickly become mainstream thinking about bifurcated lesions.

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Companies mentioned in this article

Abbott Laboratories Inc.

Abbott Vascular Devices

Boston Scientific Corp.

Cappella Inc.

Columbia University

New York-Presbyterian Hospital

Dartmouth-Hitchcock Medical Center

Devax Inc.

Edwards Lifesciences Corp.

Johnson & Johnson

Medtronic Inc.

Minvasys

Stanford University

Stanford University Medical Center

Stentys SAS

Trireme Medical Inc.

Tryton Medical Inc.

University of Utrecht

University Medical Center Utrecht

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