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.
- Gore wins European approval for vascular graft
W. L. Gore & Associates received CE Mark approval for its Propaten vascular graft for hemodialysis access. Arteriovenous (AV) Grafts are used to create a conduit for repeated blood access during hemodialysis, allowing blood to be withdrawn from the body and cleansed when a patient has End Stage Renal Disease (ESRD), commonly referred to as kidney failure. During the implantation procedure, a vascular graft is implanted through two small incisions in the arm. Once a tunnel is created under the skin, one end of the vascular graft is sewn to the artery and the other to the vein. Blood can then flow rapidly from the artery through the vascular graft into the vein producing the higher flow rates needed for the hemodialysis process.
- Gore nets FDA approval for new Viabahn endoprosthesis
Gore also won Food & Drug Administration approval for the Viabahn Endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system. The Viabahn device is designed to percutaneously treat peripheral artery disease by relining the native vessel. This next generation device enables a reduction in delivery profile to 6 Fr for 5 and 6 mm devices and 7 Fr for 7 and 8 mm devices and is delivered over a 0.018" or 0.014" guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the Superficial Femoral Artery (SFA) and Iliac Artery.
- ArthroCare wins FDA clearance for vertebral augmentation device
ArthroCare Corp. (NSDQ:ARTC) received clearance from FDA to market its second-generation Parallax Contour-enhanced Vertebral Augmentation Device specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral augmentation, also referred to as vertebroplasty or kyphoplasty, is commonly used to treat painful vertebral compression fractures. This new lower profile device makes it easier for surgeons to operate in tight spaces and to provide additional tactile and audible feedback to improve ease of use during the void creation process. The Contour-enhanced utilizes a curved, movable stylet to displace cancellous bone within vertebrae, creating a void. This void is then filled with bone cement to stabilize the fracture. The Contour-enhanced is indicated for procedures to create a void in the vertebral body and fill the void with Parallax Acrylic resin (bone cement).
- Vapotherm receives FDA 510(k) clearance and CE Mark approval for Flowrest
Vapotherm received 510(k) clearance from the FDA for the Flowrest homecare device. The device also recently received CE Mark approval. The Flowrest delivers warmed, humidified high-flow breathing gases to patients via nasal cannula. Utilizing patent pending humidification and breathing circuit technology, the device is designed to maximize ease of use and patient comfort, both of which are critical in homecare and other low acuity settings.
- Delcath achieves ISO 13485 certification
Delcath Systems Inc. (NSDQ:DCTH) achieved ISO 13485:2003 Certification — an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regulatory requirement of the EU’s Medical Device Directive, and represents an important step toward attaining European CE Mark approval for the Company’s proprietary Hepatic ChemoSAT Delivery System.
- Delcath receives "refusal to file" letter from FDA
Delcath also received a "refusal to file" letter from the FDA for the New Drug Application for its proprietary chemosaturation system used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride. Delcath expects to submit a formal meeting request to the FDA this week and intends to meet with the FDA at the earliest opportunity to discuss the issues raised and to confirm our understanding of the remedies required for the filing to be accepted. Based on management’s current understanding of the information in the FDA’s letter, the Company intends to resubmit the NDA by Sept. 30, 2011. In accordance with application regulations, the FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on Dec. 22, 2010. Neither the acceptance nor non-acceptance of the NDA filing is a determination of the approvability of the chemosaturation system.