Abbott Laboratories (NYSE:ABT) won aproval from the FDA for expanded use of its RX Acculink carotid stent system.
The expanded indication means the stent system can be used to treat carotid artery disease patients who have a standard risk for complications from carotid endarterectomy surgery, a procedure that entails cutting open a patient’s neck artery and scraping out blockages.
The FDA in 2004 granted the RX Acculink pre-market approval (PMA) only for patients who were at high risk of adverse events if they underwent the surgery.
The expanded indication follows the release of data from a 2,307-patient study of the device last summer. The "Carotid Revascularization Endarterectomy Versus Stenting Trial," — or "CREST" — compared the surgical procedure to carotid stenting with the RX Acculink device and demonstrated that stenting resulted in an adverse event rate of 7.2 percent, compared with 6.8 percent for surgery.
The FDA’s Circulatory System Devices Panel in January recommended that the benefits of using the stent in standard-risk patients outweighed the risks of surgical treatment, paving the way for the approval.
As a condition of the expanded PMA, the FDA is requiring Abbott to conduct a post-approval study that will follow new patients treated with RX Acculink for at least three years to confirm the results of the CREST study, according to the watchdog agency.
Abbott still faces a major hurdle: Convincing the Centers for Medicare and Medicaid Services to approve reimbursement for standard-risk patients.
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.
- FDA approves new Medtronic cardiac device leads
Medtronic Inc. (NYSE:MDT) announced the FDA approval and launch of the Attain Ability Plus and the Attain Ability straight left-heart leads for use with cardiac resynchronization therapy (CRT) devices in treating heart failure patients. The two new dual-electrode leads are the latest offering in a line of advanced left-heart lead options that fit through the Attain Select II sub-selection catheter delivery system and navigate a variety of patient vein anatomies to enhance success during the CRT implant procedure.
- FDA approves popular stent drug for rare cancer
Novartis’ (NYSE:NVS) Afinitor (everolimus) won FDA approval for the treatment of patients with progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic). Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the U.S. each year.
Everolimus is also used in Abbott Labs’ Xience and Promus drug-eluting coronary stents as an immunosuppressant to prevent restenosis, or the narrowing of a blood vessels due to the build-up of plaque.
- Hotspur Technologies’ IQCath catheter wins CE Mark approval
Hotspur Technologies Inc. received CE Mark approval for the IQCath Balloon Dilatation Catheter, allowing the company to introduce the novel technology to markets outside of the U.S. The IQCath catheter utilizes Hotspur’s technology to combine multiple functions into a single device that can potentially make procedures to open blocked blood vessels more efficient and cost-effective than current treatment options.
- Solta lands FDA 510(k) clearance for "Clear + Brilliant" device
Solta Medical, Inc. (NSDQ:SLTM) received FDA 510(k) clearance of its new Clear + Brilliant laser aesthetic treatment, which will officially launch at the World Congress of Dermatology in Seoul, Korea on May 25. Clear + Brilliant, which previously received CE mark, is a treatment based on fractional laser technology that is performed in a professional setting.
- Sorin wins CE Mark for Paradym RF ICDs and CRT-D
Sorin Group won CE mark approval for the PARADYM RF1 family of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-D). The SafeR and Parad+, PARADYM RF remote monitoring-enabled ICDs and CRT-D are designed with proprietary algorithms to automatically adjust to provide individualized, appropriate therapy.
- Caldera Medical wins CE Mark for Desara Mini
Caldera Medical achieved CE Mark certification for its Desara Mini implant, an extension of its popular Desara brand for the treatment of Stress Urinary Incontinence. Desara Mini combines the proven Desara mesh with a secure fixation system that allows for sling placement with a single incision.
- Keller Medical granted CE Mark for breast implant delivery device
Keller Medical Inc. announced today that it has received CE approval for the Keller Funnel gel implant delivery device. Receiving the CE mark allows the Company to begin marketing and distributing the product in all European member (EU) states. Approved by the FDA in August 2009 as a single use device, Keller Medical has tripled its Funnel sales in a year over year comparison and captured 20% of U.S. surgeons performing silicone breast implant augmentations since its launch 20 months ago.
- Xlumena wins CE mark for Axios stent system
Xlumena Inc. received CE Mark approval for its revolutionary AXIOS Stent and Delivery System (AXIOS). The AXIOS is the first stent designed for endoscopic ultrasound-guided translumenal therapy and is indicated for drainage of pancreatic pseudocysts. Having achieved this important milestone, Xlumena will begin a targeted commercial launch of the AXIOS in select European markets.
- Sectra wins FDA clearance for MicroDose mammography modality
First-of-its-kind technology enables women to benefit from significant reduction of radiation exposure Women in the US will now have the same opportunity as million of European women already have; to undergo mammography with significantly lower radiation dose. This is the result of FDA clearance of the Swedish IT and medical technology company Sectra’s digital mammography system, Sectra MicroDose Mammography