MASSDEVICE ON CALL — St. Jude Medical Inc. (NYSE:STJ) and Medtronic Inc. (NYSE:MDT) logged some important wins in the neurostimluation arena this week, making progress on treatments for pain, depression and high blood pressure.
St. Jude announced yesterday that it won U.S. Food & Drug Administration clearance for its Epiducer lead system, a device that sends electrical impulses to mask or interrupt pain signals via leads implanted near the spine. The Epiducer system is the first FDA-cleared device of its kind to allow multiple leads to be inserted via a single entry-point, rather than through multiple incisions.
On Monday the St. Paul, Minn.-based company announced FDA approval to expand its BROADEN study, investigating the use of neurostimulation in treatment of depression. Researchers will continue to study the effects of sending mild electrical impulses to the a region of the brain associated with appetite and sleep, mood an anxiety, memory formation and self-esteem.
The expansion brings the study to up to 20 sites across the U.S., and approves enrollment of up to 125 patients.
Fridley, Minn.-based Medtronic wona conditional go-ahead to begin trials of its Symplicity catheter system for treatment of hypertension. The device uses a radiofrequency generator that is inserted into the renal artery via the femoral artery in the upper thigh. The generator is placed near the kidneys and delivers a lower-power radio-frequency that "deactivates" the nearby sympathetic nerves to lower blood pressure.
The Symplicity device is already approved in the European Union and Australia, according to Medtronic officials.
Medtronic Inc. (NYSE:MDT) launched its Activa device for the treatment of Parkinson’s disease earlier this year, after winning CE Mark approval in the European Union for it’s deep-brain stimulator for treatment of epilepsy last fall.
St. Paul, Minn.-based St. Jude won CE Mark approval for its Athena deep-brain stimulation programmer, designed to help physicians control the amount of current delivered to patients’ brains to treat Parkinson’s disease, in September 2010. The company landed Australian approval in January 2011.
Can heart pumps go cord-free?
Mechanical heart pumps may be freed from the power cords that protrude through a patient’s belly and are prone to infection thank to a wireless power system developed by researchers at the University of Washington and University of Pittsburgh Medical Center.
The concept uses a transmitting coil that sends out electromagnetic waves at a certain frequency, and a receiving coil absorbs the energy and uses it to charge the battery in the pump, similar to the charging pads used by electric toothbrushes except the sending and receiving coils don’t’ need to come into direct contact.
Although cardiac assist pumps were originally designed to be temporary measures for patients waiting on a heart transplant, technological advances mean the devices often stay in patients for years. The power cord that sticks out of the patients chest is the leading cause of rehospitalization, thanks to a proclivity for infection.
"My primary interest is to help heart failure patients recover, and they can only recover if they are not tethered to a battery or external power supply so they can exercise and train their heart to recover," said Dr. Pramod Bonde, a heart surgeon at the University of Pittsburgh Medical Center, in the release. "With wireless technology patients can be free and they can have a chance to move around and exercise like normal human beings."
GOP targets IPAB
Republican continue their attack on President Barack Obama’s health care overhaul by shining a spotlight on a lawsuit filed against the Independent Payment Advisory Board, designed to evaluate and make recommendations on Medicare reimbursement practices, Healthwatch reported.
GOP members liken the panel to a "rationing board," and challengers argue that Congress is giving up too much of its power to the IPAB to make important health care decisions for the nation’s elderly.
The American Medical Assn. joined Republicans in challenging the creation of the panel late last week, agreeing that the authority over Medicare needs to stay with Congress.
"The IPAB puts important health care payment and policy decisions in the hands of an independent body that has far too little accountability," AMA president Cecil Wilson said in a letter. "Major changes in the Medicare program should be decided by elected officials."
The IPAB, created by the 2010 Patient Protection and Affordable Care Act, takes over the role of making recommendations on Medicare reimbursement practices, once the responsibility of Medicare Payment Advisory Commission which was established in 1997.
With MedPAC all recommended changes to Medicare reimbursement required an act of Congress to take effect, but the new IPAB’s recommendations automatically take effect and require an act of Congress to overrule them.
Nearly every U.S. hospital reports drug shortage in last six months
Almost every U.S. hospital surveyed reported a prescription shortage in the last six months, most requiring delays in treatment, according to a survey by the American Hospital Assn.
Of officials surveyed at 820 hospitals, 99.5 percent reported at least one shortage in the last six months, and over half reported 21 or more shortages, Healthwatch reported. More than 80 percent said they had to delay treatment, and nearly 70 percent had to give patients a less effective drug than recommended.
Incentives drive EMR adoption, but many hospitals cling to paper
While nearly three-quarter of hospitals expect to claim federal "meaningful use" incentives for electronic health records, even more expect to stay with paper for at least five more years, according to a survey by information management company Iron Mountain Inc.
In a survey of 200 health information professionals, the report found that most hospitals aren’t prepared to fully make the transition from paper to digital records. Most rely on full-time employees to scan the backlog of paper records, and just about half say they’ve scanned what they need and managed to stay within budget.