The FDA granted Covidien plc (NYSE:COV) pre-market approval for its brain aneurysm treatment device.
The Mansfield, Mass.-based company designed its new endovascular device, aptly called the Pipeline, to redirect blood flow away from an aneurysm so an embolization can be performed.
It is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy and indicated for treatment of "large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments," according to the company. A "giant" aneurysm can exceed 1.25 inches in size, according to the FDA.
Large or giant, wide-neck aneurysms "remained an unmet clinical need until now," Brain Aneurysm Foundation executive director Christine Buckley said in prepared remarks.
The Pipeline gives "neurointerventional surgeons an alternative to open surgery or placement of materials such as coils or a liquid embolic," Center for Devices and Radiological Health Office of Device Evaluation acting director Christy Foreman said in prepared remarks.
The Pipeline device won CE Mark (Conformité Européenne) approval in Europe and has been sold outside the United States since July 2009 when it was still made by ev3 Inc., which Covidien acquired last July. Covidien plans to begin selling the device in the U.S. this quarter, the company said.
The Pipeline’s approval had been expected after an FDA advisory panel in March recommended that the agency approve the device. The FDA had also granted ev3 Inc. expedited review for its PMA application for the device, a month before Covidien closed its buyout of the company.
"Although likely not material to COV’s financials near-term — due to a relatively modest initial market opportunity [$100-150 million and about 2,000 patients per year] and an expected controlled launch by COV— COV now has yet another highly differentiated product to sell in its growing portfolio of innovative solutions," Leerink Swan analyst Rick Wise wrote in a note to investors.
COV shares rose 31 cents, or .6 percent, to close at $52.72.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Philips wins 510(k) clearance for Ingenia MRI system
Royal Philips Electronics (NYSE:PHG) announced the U.S. availability of the Ingenia MRI system, the first-ever digital broadband magnetic resonance imaging solution. Previously available in Europe, Canada and Japan, the system has received 510(k) clearance from the FDA. Ingenia MRI delivers exceptional image clarity, scanning efficiency and scalability designed to advance diagnosis and radiology workflow.
- FDA clears Mandometer eating disorders treatment
The FDA announced on March 31 that it had cleared Mandometer for the treatment of patients with eating disorders. Mandometer is a device that provides biofeedback allowing individuals to monitor their rate of eating and their development of satiety during meals and in comparison to those eating normally.
- Alphatec Spine wins clearance for Solus fusion system
Alphatec Holdings Inc. (NSDQ:ATEC), the parent company of Alphatec Spine Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders announced it received 510(k) clearance from the FDA for its Solus Anterior Lumbar Interbody Fusion (ALIF) system.
- Alere earns NCQA certification for health information line
Alere Health LLC announced that it has achieved the National Committee for Quality Assurance (NCQA) Health Information Products Certification for Health Information Line. The accreditation is for Alere’s Nurse24(SM) program − a 24/7 nurseline staffed by highly experienced, registered nurses that empowers individuals to make smarter healthcare decisions by providing immediate clinical support for everyday health issues and questions that otherwise might lead to unnecessary doctor or emergency room visits.
- Spectranetics announces approval of LLD in Japan
Spectranetics Corp. (NSDQ:SPNC) announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for the LLD lead locking device, which is used for the removal of pacemaker and defibrillator cardiac leads. The LLD secures leads along the entire length of their hollow inner lumen, permitting physicians to apply steady traction on the lead during the removal process.
- IRIS International wins FDA clearance for urinalysis workstation
IRIS International Inc. (NSDQ:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, announced today that, following recent 510(k) market clearance on March 24 from the FDA.
- NeuroVasx wins FDA approval for cPAX aneurysm treatment system
NeuroVasx announced that the FDA has approved the cPAX Aneurysm Treatment System as a Humanitarian Use Device (HDE) for the treatment of large, giant and wide-neck cerebral aneurysms, which are typically the most difficult to treat. The HDE allows for the treatment of up to 4,000 patients per year in the U.S.
- Titan Spine wins CE Mark for Endoskeleton fusion devices
Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, received CE Mark approval to commercially release its line of Endoskeleton lumbar interbody fusion devices in Europe. The implants, which consist of the Endoskeleton TA (ALIF), Endoskeleton TT (TLIF), and Endoskeleton TO (PLIF and Oblique), feature a unique roughened titanium surface topography that is designed to promote rapid bony integration and subsequent fusion.
- Reverse Medical wins CE Mark intracranial distal access catheter
Reverse Medical Corp. received CE Mark approval for its ReFlex™ A+ Catheter for intracranial distal access, delivery and aspiration. The ReFlex A+ Catheter is uniquely designed to provide endovascular intracranial access during interventional neurovascular procedures.
- Hospira submits 510(k) application for Symbiq modifications
Hospira Inc. (NYSE:HSP), a provider of clinical information and medication delivery technologies, today announced that the company submitted a 510(k) application with the FDA for modifications to the Symbiq infusion system. The submission is one of the first developed to align with the recent FDA draft guidance for 510(k) infusion pump clearances.
- CryoLife files IDE to begin trials for PerClot
CryoLife Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced that it has filed an "Investigational Device Exemption" with the FDA to begin clinical trials for the purpose of obtaining a PMA to distribute PerClot in the U.S. to control bleeding during surgical procedures or following traumatic injuries.