Group purchasing organization Novation put the spotlight on St. Jude Medical (NYSE:STJ) in the latest issue of the GPO’s EuroPCR report, CVWatch.
The dispatch, "intended to promote innovation, while providing clinical and economic highlights of these new technologies that have a high probability of impacting the member hospitals we serve," highlighted St. Jude and a slate of the company’s cardiovascular devices, including the Nanostim wireless pacemaker and Amplatzer left atrial occluder.
"St. Jude Medical has evolved its product offering both vertically and horizontally to be a significant supplier to the cardiovascular market," according to the report. "The hospital’s innovation product pipeline, including a 4-electrode pacing lead, lead-less pacing, renal denervation and TAVI, potentially will impact the hospitals and markets during the next several years."
The commendation comes amid harsh times for St. Jude, which just last week announced large-scale business restructuring and mass layoffs that may have been related to cost-savings efforts ahead of the 2.3% medical device tax taking effect in less than 4 months.
The company has also taken heavy hits from ongoing softness in the U.S. cardiac rhythm devices market and has weathered a spate of FDA warnings and renewed concern over its recalled Riata heart wires.
STJ shares closed with a 1.8% boost at $38.42 today.
Novation highlighted 9 bright points in St. Jude technologies, which the GPO predicted would influence the cardiovascular health market:
- Quadra Assura CRT-D
- Accent MRI Conditional Pacemaker
- Nanostim Wireless Pacemaker
- Portico Transcatheter Aortic Valve
- Enlightn Renal Denervation System
- Amplatzer Left Atrial Appendage Occluder Device
- CardioMEMS Wireless Sensing
- MediGuide Fluoroless Navigation
- Ilumien PCI Optimization System
St. Jude’s Quadra Assura left-ventricular pacing system features 4 electrodes that can be configured into 10 different pacing configurations based on patient need or physician preference.
"Because the physician can adjust pacing configurations, the technology reduces common problems associated with implantable Cardiac Resynchronization Therapy systems, leads displacement and, ultimately, results in fewer surgeries for patients," according to the report.
The device hit markets in Europe in May 2010, launched in India in September 2011, won FDA approval in November 2011 and reached Japan earlier this summer.
The device has garnered lofty praise from some analysts. Last March bullish outlooks on the device shot STJ shares to new highs on Wall Street.
The Accent MRI is St. Jude’s 1st MRI-friendly device, featuring a safe-mode allowing patients implanted with the device to undergo full-body scanning.
St. Jude in April 2011 won CE Mark approval in the European Union for the Accent system, but is not yet cleared for the U.S. market.
Still in development, the lead-free Nanostim device will be implanted directly into a patient’s heart, featuring battery life equal to existing pacemakers.
St. Jude has rights to the technology through strategic investments in Nanostim Inc.
Read MassDevice.com’s interview with Novation CEO Jody Hatcher
St. Jude’s Portico transcatheter aortic valve implantation technology is the only valve that can be re-sheathed in the delivery catheter, repositioned at the implant site, or retrieved before it is released from the delivery system, according to the company.
The device, in the midst of a European clinical trial to support CE Mark approval, is a few steps behind competitors Edwards Lifesciences (NYSE:EW), whose Sapien won FDA approval in November 2011, and Medtronic (NYSE:MDT), which recently hit new milestones for its CoreValve TAVI system.
The Enlightn system is another product targeting a hot market, but St. Jude’s device has certain perks, Novation noted.
"The product is unique, having multiple electrodes which potentially saves time during the procedure, as four points of ablation can be performed without catheter repositioning."
St. Jude recently touted preliminary study results finding that the newly cleared Enlightn renal denervation system lowered patients’ blood pressure by twice as much as rival systems in the same amount of time.
St. Jude in May won CE Mark approval and announced commercial launch of the Enlightn device.
The transcatheter Amplatzer device is designed to seal off the left atrial appendage in the heart, preventing strokes or other adverse events that may be the result of blood clots within the abnormal blood vessels.
St. Jude in June won FDA 510(k) clearance for its next-generation Amplatzer vascular plug 4, which the company calls the "industry’s first vascular plug that can be delivered using a standard diagnostic catheter."
St. Jude’s proprietary CardioMEMS technology includes a wireless implantable sensor and an external module that transmits data in real time without batteries.
"The monitor is designed to be implanted using a catheter and improve the management of severe chronic cardiovascular diseases, such as heart failure, hypertension and aneurysms by monitoring cardiac output, blood pressure and heart rate data."
St. Jude has rights to the technology and owns about 20% of Atlanta-based CardioMEMS Inc.
The MediGuide magnetically locates, tracks and projects a catheter based on a previously recorded image, reducing the need for multiple scans.
The Ilumien device is the 1st system to combine optical coherence tomography and fractional flow reserve technologies to measure the severity of blood flow blockages in the coronary arteries while measuring important vessel characteristics.
The system won FDA clearance in October 2011, just months after gaining CE Mark approval.
