Abbott Laboratories (NYSE:ABT) landed approval from European regulators for its drug-eluting bio-resorbable Absorb stent.
The Abbott Park, Ill.-based healthcare products conglomerate said the device, like other stents, works by opening up and providing support to clogged arteries. Unlike its metal counterparts, however, the device is designed to dissolve within approximately two years after implantation, according to Abbott. The device is comprised of polylactide, a bio-compatible substance used in medical implants such as resorbable sutures. Because it eventually disappears, the necessity to treat stent recipients with long-term dual anti-platelet therapy "may be reduced," the company said.
Abbott’s planning a commercial launch for the device in Europe by the end of 2012, but said it will make select sizes in limited numbers available this year.
Abbott touts the device as the "world’s first drug-eluting bio-resorbable vascular scaffold for the treatment of coronary artery disease," but several other companies are also developing bio-resorbable stents. San Diego-based Reva Medical Inc. raised $84.8 million in an initial public offering on the Australian Securities Exchange in December. Arterial Remodeling Technologies, a French company that uses technology developed in part at the Cleveland Clinic, raised $8.5 million in venture capital funding in September to further develop its bio-degradable stents. MultiCell Technologies Inc. (OTC:MCET) is working on a stent that combines two drugs aimed at reducing restenosis — salicylate, aspirin’s active ingredient, and sirolimus. That polymer stent is designed to dissolve completely over the course of a year.
Abbott is planning a 500-patient, 40-site European clinical trial to compare Absorb to Abbott’s Xience Prime drug-eluting stent.
Here’s a roundup of other companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- ProGEL Platinum surgical sealant wins CE Mark
Neomend Inc., a maker of sealant and adhesion-prevention products for the surgical marketplace, announced it has received CE (Conformité Européenne) Mark approval for the company’s ProGEL® PLATINUM Surgical Sealant. “This important milestone will enable us to help surgeons more effectively treat lung air leaks during lung resection surgery in countries outside the U.S., where there are many such procedures due to the prevalence of lung cancer,” said CEO David Renzi in prepared remarks.
- NxStage lands FDA clearance for therapeutic plasma exchange cartridge
NxStage Medical Inc. (NSDQ:NXTM), a leading manufacturer of innovative dialysis products, announced that it recently received clearance from the Food & Drug Administration to market its Therapeutic Plasma Exchange (TPE) cartridge for use with the NxStage® System One™ in a clinical environment.
- Varian Medical Systems receives 510(k) clearance for its proton therapy system
Varian Medical Systems (NYSE:VAR) received FDA 510(k) clearance for the Varian Proton Therapy System which generates protons for precision radiotherapy of lesions, tumors, and conditions anywhere where radiation treatment is indicated. It is the first working system capable of delivering precise intensity modulated proton therapy (IMPT) using pencil beam scanning technology.
- diaDexus announces FDA clearance for automated PLAC Test
diaDexus Inc. (OTC:DDXS), a diagnostics company focused on the development and commercialization of in vitro diagnostic products addressing unmet needs in cardiovascular disease, announced that the FDA has cleared for marketing the automated version of its proprietary PLAC® Test. This PLAC Test product format, based on turbidimetric immunoassay (TIA) technology, is designed to run on most clinical chemistry analyzers, significantly expanding the number of clinical labs and physician offices that are able to offer the PLAC Test.
- Critical Diagnostics receives CE Mark for Presage ST2 assay
Critical Diagnostics announced that it received CE Mark for its high sensitivity Presage ST2 Assay and is commencing commercialization in Europe. The product is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome. This regulatory milestone marks the first time that an assay has become commercially available for the clinical measurement of the biomarker soluble ST2.
- Corgenix announces 28 percent increase in reimbursement rate for AspirinWorks test
The AspirinWorks® Test from Corgenix Medical Corp. (OTC:CONX), reimbursed under CPT code 84431, has received a 28 percent increase in reimbursement according to the 2011 Clinical Laboratory Fee Schedule. The fee schedule is published annually by the Centers for Medicare & Medicaid Services (CMS).
- Viveve obtains CE Mark for gynecologic treatment of vaginal laxity
Viveve Inc., a development stage women’s health company, announced that it received CE Mark approval for the use of its Viveve System for the non-surgical treatment of laxity of the vaginal introitus, after childbirth, to improve female sexual function.
- Crospon receives FDA approval for EndoFLIP
Crospon, an Irish medical device developer based in Galway, has announced that the company received clearance from the FDA to market a new imaging catheter for the measurement of sleeves created during bariatric surgery.
- FDA clears ImageSenseTM Technology for use with Colposcopy
STI Medical Systems, announced that FDA gave clearance to the Company’s precedent-setting ImageSense™ technology for use in colposcopy. This new proprietary technology represents an entirely new way of presenting digital imagery in the doctor’s office, and is first-in-class for colposcopy. This represents an advance in colposcope system technology as colposcopes used in evaluating cervical neoplasia have remained largely unchanged for over 50 years.
- Gore receives FDA approval for GORE C3 delivery system for GORE Excluder AAA endoprosthesis
W. L. Gore & Associates announced that it has received approval from the FDA to market the GORE® C3 Delivery System to deploy the GORE® EXCLUDER® AAA Endoprosthesis as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm (AAA). The GORE C3 Delivery System enables physicians and interventionalists to reposition the GORE EXCLUDER Device prior to final release from the delivery catheter.
- Celera files PMA application for KIF6 genotyping assay
Celera Corp. (NSDQ:CRA) announced that it has submitted a Pre-market Approval application (PMA) to the FDA for its KIF6 Genotyping Assay, a new molecular in vitro diagnostic test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.