A Medical Device Daily
Paracor Medical (Sunnyvale, California) said it has received CE-mark approval from its notified body, BSI, for the initial two products based upon its HeartNet technology platform.
The approval will allow the expanded use of Paracor's HeartNet and HeartNet-D products to treat patients suffering from systolic heart failure within the member countries of the European Union.
The HeartNet implant, an elastic nitinol structure, provides support to the walls of the heart's pumping chambers, the ventricles. This elastic support augments the function of the heart, and is designed to attenuate or reverse the negative remodeling, or enlargement, associated with the advanced stages of heart failure.
The second product, HeartNet-D, incorporates defibrillation electrodes within the elastic structure of the device, providing the potential to address arrhythmia problems that can be life-threatening to heart failure patients. Paracor said the HeartNet-D is compatible with the leading commercially available implantable defibrillation systems.
Both products are delivered in a procedure typically lasting about one hour through a less invasive mini-thoracotomy approach, avoiding some of the problems associated with cardiac procedures that employ an open chest or sternotomy procedure.
The CE-mark application was approved based upon clinical studies assessing the impact of HeartNet and HeartNet-D therapy in more than 50 patients. The studies indicated that, on average, treated patients experienced statistically significant improvements in structural parameters (left ventricular end systolic and diastolic diameters, left ventricular volumes), exercise parameters (6 minute walk), and quality of life measures (Minnesota Living with Heart Failure instrument) through six months of follow-up, with continuing positive trends at the twelve month time frame.
In addition, patients treated with the HeartNet-D therapy maintained appropriate defibrillation safety margins through six months of follow-up testing.
In commenting on the CE mark certification, William Mavity, Paracor Medical's president/CEO, noted, "We are extremely pleased to have succeeded in obtaining this significant approval, as it indicates compliance with applicable development, manufacturing and quality standards that are recognized globally. Over the coming months, we will be considering appropriate strategies to enable the company to leverage the CE mark status of our products and broaden the clinical acceptance of the HeartNet therapy."
Paracor is currently evaluating the HeartNet therapy in an FDA approved clinical trial in North America that intends to enroll more than 270 treatment and control patients. Designated PEERLESS-HF (Prospective Evaluation of Elastic Restraint to LESSen the effects of Heart Failure), the trial will compare the impact of the HeartNet treatment plus optimal medical and device therapy, per current guidelines, to results in patients who continue to receive optimal therapy alone.
Paracor is a venture capital-financed medical technology company focused on the development of a platform of technologies and products to treat heart failure.
CE-mark for Endogun's EndoFast Reliant
Endogun Medical Systems (HaOgen, Israel), a manufacturer of solutions for minimally-invasive fastening of soft tissue, announced today that it has received European CE-mark approval to market its next-generation, single-incision, trans-vaginal EndoFast Reliant device for repair of pelvic organ prolapse and stress urinary incontinence.
"The CE mark was received in close proximity to the FDA approval that we got earlier this quarter for the single-use, disposable EndoFast Reliant product," said Chairman Elad Naggar. "These regulatory approvals welcome Endogun into the community of innovative urogynecology products, aimed to reduce the invasiveness of key women's health procedures, and offering quality-of-life solutions in a safe and effective manner."
Pelvic organ prolapse occurs in women, often following multiple births or excess weight, and develops as a result of weakening of the pelvic muscles which support internal organs (womb, bladder, rectum and vagina). Side effects of this condition include discomfort, a feeling of heaviness, and pain, and the disorder carries the risks of inflammation and infection.
Endogun said more than 600,000 procedures are performed annually in the U.S. and Europe combined, with direct costs of associated surgical equipment reaching hundreds of millions of dollars. It said estimates suggest that close to 7 million women are in need of such treatment, with the gap between the potential market size and the actual number of procedures performed to date likely stemming from the fact that the current surgical offerings are "significantly invasive" and require "substantial surgical skills."
TigerWire launched by St. Jude
St. Jude Medical (St. Paul, Minnesota) has reported CE-mark approval and the European launch of the TigerWire Steerable Guidewire.
The newest member of the St. Jude Medical GuideRight family of steerable guidewires, the TigerWire device is designed to enhance physicians' ability to steer through challenging peripheral arteries.
The company said the TigerWire Guidewire's tip is designed with "enhanced flexibility" to aid in navigation through the vessels. Its supportive design provides distinct zones of flexibility that make it easier for physicians to track and position the guidewire through challenging anatomy.
"As physicians treat more complex peripheral cases, the need for versatile wires has grown. The TigerWire Steerable Guidewire has been engineered for improved steerability and support," said Denis Gestin, president of St. Jude Medical's International Division. "It gives physicians a tool with enhanced tactile feel which allows them to access difficult-to-reach vessels when performing complex diagnostic and interventional procedures."