| January 4, 2013 | News for medical technology professionals |
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- Abbott's heart stent gains FDA approval
The FDA has granted Abbott Laboratories approval for its Xience Xpedition system, which the company said is targeted for immediate release in the U.S. The heart stent administers the drug everolimus to aid in the prevention of blood vessel reclogging. Reuters
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| Business & Market Trends | | |
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- CardiOx seeks $4 million to support launch of heart defect test
CardiOx is looking to raise $4 million in a funding round as the company awaits regulatory clearance for its flagship product: a noninvasive test to detect a heart defect called patent foramen ovale. The Columbus, Ohio-based company will use the money to launch the assay during the first half of the year, said CEO Larry Heaton. MedCityNews.com
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| International Developments | | |
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| Science & Health | | |
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- Covidien's device shows promise in venous reflux study
Covidien said its ClosureFast ablation catheter showed positive results in a multicenter study of European patients with superficial venous reflux who were treated with the device. Of the 233 study participants who were available for evaluation at five years, 95% were found to be cleared of pathological venous reflux and 92% reported full closure of the treated vein. MassDevice.com (Boston)
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| Emerging Technologies | | |
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- Device uses electrical stimulation to treat severe gastric reflux
EndoStim has created a device that uses electrical stimulation to treat patients with severe gastroesophageal reflux disease. The system, which consists of a pulse generator implanted in the abdomen subcutaneously via laparoscopic surgery, already has marketing approval in Europe. The company is now seeking $12 million to help it pursue FDA approval for the device. MedCityNews.com
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| Industry Service Providers | | |
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| Government & Regulatory | | |
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- FDA gives Alphatec nod on 2 spinal devices
Alphatec Spine has gained 510(k) clearance from the FDA to market its Pegasus system, an anterior interbody device delivered to the cervical spine without the need for impaction. The agency also cleared the company's ILLICO FS Facet Fixation System, which aids surgeons in stabilizing spinal segments without using rods and screws. BeckersOrthopedicAndSpine.com
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- Medical Device Reimbursement Workshop
Tuesday, Feb. 26 – Wednesday, Feb. 27
Sheraton Crystal City, Arlington, Va.
AdvaMed MTLI’s workshop for medical technology reimbursement professionals will provide the road map to successfully navigate the many potential pitfalls. After an overview of reimbursement issues, the workshop will drill down to coding systems, technology assessments and differences in inpatient and outpatient payment systems. Hear from experts on how to negotiate CMS coverage. Learn how to plan for the new health care reform landscape, deal with comparative effectiveness and manage international reimbursement. Visit MTLI online for more information.
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A regulatory filing shows Minerva Surgical has secured $20 million in a recent funding round. The Cupertino, Calif.-based startup is the maker of an endometrial ablation device that treats excessive menstrual bleeding using RF Argon Plasma Energy stored in a balloon. 
