|[October 28, 2013]
St. Jude Medical Reports Positive Clinical Outcomes from Portico Heart Valve Study
ST. PAUL, Minn. --(Business Wire)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced positive results for the 23 and 25 mm Portico™
Transcatheter Aortic Heart Valves in the Portico Transfemoral CE Mark
Trial (Portico TF CE Trial). Patients enrolled in the study experienced
a significant improvement in valve function at 30 days. The preliminary
findings indicate exceptional hemodynamic performance (the ability to
maximize blood flow) and improvement in the severity of heart failure
symptoms as measured by the New York Heart Association (NYHA) Functional
Classification System. The data was presented today at the 25th
annual Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium, sponsored by the Cardiovascular Research Foundation.
Image of the 23 mm Portico(TM) Transcatheter Aortic Heart Valve, one of two valves being evaluated in the Portico Transfemoral CE Mark Trial. The Portico valve and transfemoral delivery system are not approved for use in the U.S. (Photo: St. Jude Medical, Inc.)
Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K.
presented preliminary data on the Portico 23 and 25 mm valves from 83
patients diagnosed with severe aortic stenosis, a narrowing of the
aortic valve that obstructs blood flow from the heart. These patients
are candidates for a transcatheter aortic valve replacement (TAVR)
procedure, as many are considered high-risk for conventional open-heart
valve replacement surgery.
Key Findings at 30 Days:
Improved hemodynamics were observed in the study, indicating a
significant increase in valve function
Mean aortic valve pressure gradient (difference between the
pressure inside the heart and in the aorta) was reduced from 45.6
mmHg (millimeters of mercury) to 8.7 mmHg
Post implant, 84.4 percent of patients were ranked NYHA class I or
class II at 30 days, improved from 77.8 percent who were ranked NYHA
class III or IV at baseline
Permanent pacemakers were implanted in 10.8 percent of patients to
correct conduction complications that can occur following TAVR
Paravalvular leak (PV leak), which occurs when blood leaks around the
edge of the valve due to inadequate sealing, was reported as follows:
PV leak defined as none-to-trivial was reported in 30 percent of
Mild PV leak was reported in 65 percent of patients
Moderate PV leak was reported in 5 percent of patients
There were no reports of severe PV leak
A very low rate of disabling or major stroke was reported in 2.4
percent and all-cause mortality was reported in 3.6 percent of patients
A low rate of vascular complications was reported in 6 percent of
Additional study results reinforce safety and efficacy of the Portico
vlves beyond 30 days in the subset of patients that have completed
longer-term follow up.
"The data presented today demonstrates the benefits of the Portico
Transcatheter Aortic Heart Valve in treating sick and critically ill
patients with symptomatic aortic stenosis, who simply cannot withstand
the rigors of a surgical heart valve replacement procedure," said Dr.
Manoharan, lead principal investigator in the Portico TF CE Trial. "The
Portico valve's self-expanding stent design and ability to be
repositioned prior to deployment helps ensure precise valve placement,
potentially improving patient outcomes and reducing the likelihood of
complications such as a post-procedural pacemaker."
The non-randomized, multi-center Portico TF CE Trial was initiated to
evaluate the Portico 23 mm transcatheter heart valve, which received CE
Mark in November
2012, and was later expanded to include the Portico
25 mm valve. Clinical results for the 25 mm Portico valve are
currently under regulatory review to support European CE Mark approval.
The Portico valve is the first transcatheter aortic heart valve that can
be completely resheathed (the process of bringing the valve back into
the delivery catheter), repositioned at the implant site or retrieved
before being released from the delivery system.
During transfemoral delivery, the Portico valve is implanted through a
small incision in the femoral artery (the main artery of the leg). The
procedure uses a catheter to deliver and position the valve in the heart
while it continues to beat. This avoids placing the patient on
cardiopulmonary bypass, where a machine takes over heart and lung
function during surgery.
"St. Jude Medical has a long history of developing world class heart
valve technologies. Today's positive results speak to our capability and
commitment to bring meaningful advancements to patients with heart valve
disease," said Frank J. Callaghan, president of the St. Jude Medical
Cardiovascular and Ablation Technologies Division.
Aortic stenosis is the most prevalent form of cardiovascular disease in
world after hypertension and coronary artery disease. Considered a
potentially life-threatening condition, the aortic heart valve becomes
calcified and does not open properly. Roughly 25 percent of people aged
over 65 have aortic valve thickening and 3 percent age 75 and older have severe
The Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery
System are not approved for use in the United States.
To learn more about TAVR or the Portico Transcatheter Aortic Heart
Valve, TCT attendees can visit the international kiosk at St. Jude
Medical, booth #617 in the Moscone Center.
For additional information about the Portico valve, visit SJMPortico.com.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world's most expensive,
epidemic diseases. The company does this by developing cost-effective
medical technologies that save and improve lives of patients around the
world. Headquartered in St. Paul Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com or follow us on Twitter (News - Alert) @SJM_Media.
This news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential
clinical successes, anticipated regulatory approvals and future product
launches, and projected revenues, margins, earnings and market shares.
The statements made by the Company are based upon management's current
expectations and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company's control and the
risk factors and other cautionary statements described in the Company's
filings with the SEC (News - Alert), including those described in the Risk Factors and
Cautionary Statements sections of the Company's Annual Report on Form
10-K for the fiscal year ended December 29, 2012 and Quarterly Report on
Form 10-Q for the fiscal quarter ended June 29, 2013. The Company does
not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20131028006759/en/
[ Back To Technology News's Homepage ]