Tryton Medical Completes Enrollment Phase of First-in-Man Study– 30 Patients With Coronary Bifurcation Lesions Treated Using Company’s Side-Branch Stent™

NEWTON, Mass.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat
bifurcation lesions, announced it completed the enrollment phase of the
Tryton First-in-Man (FIM) Study. The multi-center clinical trial
evaluated the safety of Tryton’s Side-Branch Stent in the treatment of
coronary bifurcation lesions. The Study was performed at the: HELIOS
Heart Center/Siegburg, Germany (Prof. Eberhard Grube); Thoraxcenter
Rotterdam (Prof. Patrick Serruys) and at the Institut Cardiovasculaire
Paris Sud, France (Marie-Claude Morice, M.D.).

“The Tryton Side-Branch Stent allowed us to successfully treat a group
of patients with challenging bifurcation lesions with an easy-to-use
system. The ability to address the side-branch definitively with a
Tryton without interfering with treatment of the main vessel is one of
the fundamental strengths of this approach. It is unclear how we could
have treated these patients without Tryton,” said Professor Eberhard
Grube, HELIOS Heart Center/Siegburg, Germany. “This technology has the
capacity to redefine the treatment of bifurcation lesions and resolve a
frequent dilemma of the interventional cardiologist,” said Professor
Serruys, Head of the Department of Interventional Cardiology,
Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands.

“We are very pleased with how the Tryton Side-Branch Stent performed in
this Study and how quickly the sites were able to incorporate a
‘save-the-side-branch’ strategy into their routine,” said H. Richard
Davis, Chief Technical Officer, Tryton Medical, Inc. “This approach
permitted interventional cardiologists to address complex bifurcation
lesions using their choice of Guide (6 Fr), guide wire, pre-dilation
strategy and main vessel sent.

The Study should provide the necessary clinical data to support a CE
mark,” Davis added.

Every year, over half a million bifurcation coronary lesions are
sub-optimally treated as no commercially available optimized solution
exists for treating bifurcation lesions. As a result, cardiologists are
forced to use a provisional strategy which avoids the deployment of a
second stent– leaving the side branch vulnerable to thrombosis and
restenosis.

Unlike other stents and techniques used to treat bifurcation lesions,
Tryton’s stent is easy-to-deliver as it uses standard equipment and
techniques compatible with 5 and 6 French guiding catheters. Tryton
greatly facilitates patient treatment, as interventional cardiologists
who use the Side-Branch Stent will no longer have to worry about the
bifurcation as they will know the side-branch will stay open and, as a
result, the interventionalist is liberated to focus on the treatment of
the main vessel using their preferred choice of standard equipment.

About Tryton Medical, Inc.

Tryton Medical, Inc. is the leading developer of stents that are
designed to definitively treat bifurcation lesions. 540,000 bifurcation
coronary lesions are sub-optimally treated every year with a variety of
time consuming and technically challenging procedures. No optimized
solution is commercially available for treating bifurcation lesions. As
a result, cardiologists are forced to use a provisional strategy which
avoids the deployment of a second stent– leaving the un-stented side
branch vulnerable to thrombosis and restenosis. The ability to
definitively treat bifurcation lesions will enable PCI-stenting to
become the new standard of care for the treatment of left main coronary
artery disease rather than bypass surgery.

Tryton Medical’s Side-Branch Stent™ has all the characteristics of a
state-of the art workhorse stent, providing proven stent coverage to
bifurcation lesions while eliminating the need for provisional stenting.
For more information on Tryton Medical, Inc.,

CASE STUDY

Provided courtesy of Drs. Müller and Grube (HELIOS Heart Center/Siegburg
Germany) A 72 year-old woman with stable angina underwent elective
cardiac catheterization followed by Tryton bifurcation stenting. Base
Line angiogram (left panel) demonstrates a high grade lesion (yellow
arrow) in the left anterior descending coronary artery involving the
origin of the first diagonal branch. This lesion was definitively
treated via a 6 Fr. guide catheter with placement of a Tryton
Side-Branch in the diagonal branch and a Cypher Select in the main
vessel. The final angiogram (Right Panel) demonstrates a successful
angiographic result.