Exactech launches Opterak revision knee system

Exactech (NSDQ:EXAC) said yesterday it launched its Opterak revision knee system and that the system has been successfully implanted in its 1st set of patients.

The revision knee system is composed of proprietary net compression molded polyethylene and is indicated for use in skeletally mature patients undergoing surgery for total knee replacements due to osteoarthritis, osteonecrosis, rheumatoid arthritis and post-traumatic degenerative problems, as well as to revise previously failed reconstructions, Exactech said.

“I was honored and pleased to be the 1st to use the new instruments and devices for revision of a failed knee replacement. The implant provided excellent early stability and kinematics, and allowed my patient to be discharged to home within 2 days. The instruments were intuitive, comfortable to use and allowed for a straightforward and accurate approach to assessing bone loss, and for re-establishing proper implant position, alignment and stability. This was a satisfying experience that I believe many surgeons will be able to share, as this innovative new implant and instrument system helps them to address the myriad of problems encountered in revision total knee replacement,” Dr. Bernard Stulberg of St. Vincent Charity Medical Center in Cleveland, Ohio said in a press release.

The pilot launch of the revision knee system will continue through 2015, with full market availability in the U.S. slated for 2016.

“We are reaffirming our commitment to revision arthroplasty. It is our goal to deliver patient-driven solutions that allow surgeons to provide a wide continuum of care. Clinical use of this knee system is the culmination of years of collaboration with world-renowned revision total knee surgery experts,” CEO David Petty said in prepared remarks.

The Gainesville, Fla.-based company said it is also pilot-launching a revision hip stem and shoulder humeral reconstruction prosthesis.

In June, Exactech said it won FDA 510(k) clearance for its Optetrak Logic constrained condylar prosthesis for revision knee arthroplasty patients.

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Bayer wins PMA for Betaconnect electronic autoinjector

Bayer (ETR:BAYN) said Monday it won FDA premarket approval for its Betaconnect electronic autoinjector for treating relapsing-remitting multiple sclerosis patients on the drug Betaseron.

The Betaconnect is the 1st and only electronic autoinjector if its kind to treat RRMS, Whippany, N.J.-based Bayer said.

“Bayer has a long legacy of supporting and providing services for the RRMS community. Betasaron was the 1st disease-modifying therapy approved by the FDA to treat RRMS patients, and today we are pleased to offer the 1st and only electronic auto injector for those living with the disease,” Bayer neurology veep Klaus Marten said in prepared remarks.

The Betaconnect device allows for customizable injection speed and depth settings, and comes with an optional back-up reminder to inform patients when its time for their next injection. The device also comes with visual and audio end-of-dose indications, as the needle injection and retraction are automatic, the company said.

“Offering new options to individuals with MS to help manage their disease is important since ‘1 size does not fit all’ when considering MS treatment,” Multiple Sclerosis Association of America CEO Douglas Franklin said in a press release.

The Betaconnect device will be available for Betasaron patients beginning in early 2016, Bayer said.

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Tryton Medical touts side branch stent study data

Tryton Medical said yesterday that data from a post hoc analysis of a randomized clinical trial of its Tryton side branch stent for patients with coronary bifurcation lesions showed reductions in target vessel failure and improved side branch diameter.

Results from the study were published in the journal Catheterization and Cardiovascular Interventions.

The 289-patient post-hoc analysis focused on patients with side branch bifurcation lesions 2.25 mm in diameter or greater.

The study reported that target vessel failure was lower in the Tryton-treated group compared to the control, and that patients treated with the company’s stent showed lower side branch diameter stentosis at 9-months follow up. There was no reported differencei n the rate of binary restenosis reported.

“Coronary bifurcation lesions present a number of challenges for interventional cardiologists because each patient can present with varying vessel sizes and there is a wide range of angulations between the main vessel and side branch. For the treatment of bifurcation lesions involving significant side branches, this analysis of the pivotal Tryton RCT provides strong support for the safety and efficacy of the Tryton Side Branch Stent compared with a provisional stenting strategy,” lead study author Dr. Martin Leon of the Columbia University Medical Center in New York said in prepared remarks.

The data came from the company’s pivotal study of its Tryton side branch stent, the largest ever conducted on coronary bifurcation lesions, which failed to meet its primary endpoint for target vessel failure in March.

Results from the 704-patient, randomized study, published this month in the Journal of the American College of Cardiology, showed that at 9 months TVF was 17.4% in the cohort treated with the Tryton device, compared with 12.8% for the control group treated with a provisional stent and balloon angioplasty (p = 0.11).

The researchers put the discrepancy down in part to a higher rate of periprocedural myocardial infarction in the Tryton group (13.6% vs. 10.1%, p = 0.19).

“Provisional stenting should remain the preferred strategy for treatment of non–left main true coronary bifurcation lesions,” the researchers wrote.

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Reva finishes CE trial enrollment for drug-eluting scaffold

Reva Medical (ASX:RVA) said it finished enrollment in its CE clinical trial of its Fantom siolimus-eluting bioresorbable scaffold for patients being treated for coronary artery disease.

Data from the 110-patient Fantom II trial will be used for the company’s CE Mark application in the European Union, which the company said it is hopeful to submit in mid 2016 at the 6-month point for the study.

“Enrollment of these 110 patients represents a significant accomplishment for the company. It moves us one step closer to our goal of commercializing Fantom, which we believe offers the performance and ease-of-use features that will enable physicians to provide the best possible care for their patients,” CEO Reggie Groves said in prepared remarks.

The scaffold is designed to restore blood flow in CAD patients and be reabsorbed by the body to allow the vessel to heal and begin to move naturally, the San Diego, Calif.-based company said.

“I have been very pleased with how easy Fantom is to implant. The delivery to the target lesion has been successful in our cases and the single-step inflation reduces the overall procedure time,” lead investigator Dr. Didier Carrié of Toulouse, France’s Hospital Rangueil said in a press release.

“The ability to visualize the scaffold under x-ray sets Fantom apart from other bioresorbable scaffolds. This unique feature will make it easier for physicians to incorporate bioresorbable scaffold use into their practice,” lead investigator Dr. Bernard De Bruyne of Aalst, Belgium’s Cardiovascular Center said in a prepared statement.

Reva Medical said it will present updated information from the trial at the Transcatheter Cardiovascular Therapeutics Conference later this month in San Francisco.

In April, Reva Medical said it would expand a trial of its Fantom bioabsorbable drug-eluting stent to Europe, a few months after launching the study in Brazil.

The 1st implantation in Europe for the Fantom II clinical trial took place in Denmark, the company said. Fantom is delivered through either the femoral artery in the groin or the radial artery in the wrist.

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Neuravi launches EmboTrap in Europe

Neuravi said today it launched its EmboTrap minimally invasive thrombectomy device for the treatment of acute ischemic stroke in Europe.

The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview in June.

“One of the things Neuravi has done that’s unique to all of our competition is we have launched a huge research effort over the last 5 years in understanding the properties of clots – the cause of ischemic stroke – and we’re going to continue to invest in that program,” Brady said.

The device is designed with a dual-layer stent-like structure as well as an integrated distal protection zone designed to reduce the risk of fragments of the clot dislodging during retrieval, the company said.

“The device has some features that no other technology has. It’s the only device that traps the clot inside the device structure, and at the same time has a tiny micro-stent that creates a blood flow channel across the device and that allows the healing process to start immediately after deployment,” Brady said. “It has an in-built, 3-dimensional fragment-catching zone at its far, most distal end to capture any particles that might break up during the procedure. The device traps the clot and is removed from the patient and nothing is left behind.”

The EmboTrap won CE Mark approval in the European Union in late 2014. The device is being sold and distributed in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden and Switzerland, Neuravi said.

“The EmboTrap device represents a new wave in innovation for stent retrievers based on clot research and a fuller understanding of the underlying challenge. We are excited to announce our launch and pleased that, following the compelling clinical data published earlier this year, use of thrombectomy devices for endovascular stroke therapy is on the rise, which should save and improve the lives of many patients,” Brady said in a press release.

Neuravi is pursuing FDA clearance for the device, and has an investigational device exemption study, the Arise II trial, slated to begin enrolling patients this year.

In June, Neuravi said it raised $21 million in a Series B  round for its Embotrap minimally invasive thrombectomy device.

The Series B round was led by European equity firm Life Science Partners and joined by existing backers Fountain Healthcare Partners, Delta Partners and the Western Development Commission, Galway-based Neuravi said.

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ANVISA updates list of technical standards required for INMETRO certification

By Stewart Eisenhart, Emergo Group

Brazilian medical device market regulator ANVISA has published a new list of technical standards to which some electrical medical devices and IVDs must comply in order to obtain INMETRO certification in the country.

The new ANVISA normative instruction, IN 04/2015, replaces IN 11/2014, and updates compliance timeframes for various IEC 60601 standards. Two major updates are included in the new instruction.

First, ANVISA has removed INMETRO certification requirements for IVD products; specifically, IVDs have been exempted from complying with IEC 61010-2-101:2002 (safety requirements for electrical equipment for measurement, control and laboratory use) and with ISO 15197:2013 (requirements for blood glucose monitoring systems designed for self-testing).

Second, the new instruction has pushed back compliance dates for some standards that Brazilian testing labs do not yet have the capacity to monitor. For example, although IEC 60601 3^rd Edition series testing is now mandatory for INMETROcertification, testing labs in Brazil are not yet able to test according to some 3^rdedition standards. In the meantime, manufacturers may submit test reports showing compliance with earlier versions of the 60601 standard in order to obtain their INMETRO certifications.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Hospi Corporation receives European regulatory approval for novel medication administration device

Hospi Corporation, a patient-centric medical device company, announced that it has received CE Mark approval— Conformité Européenne, which is required for sale of medical products in the EU and other international countries—for the company’s flagship product, the Macy Catheter.  Hospi also received ISO 13485 Certification, demonstrating that its quality systems conform to world-class standards.

“These developments support our plans to broaden distribution of the Macy Catheter and our continued commitment to quality,” said Igal Ladabaum, CEO at Hospi. “The CE Mark approval is an important milestone and we’re thrilled to be able to bring the many benefits of the Macy Catheter to patients and providers in Europe.  As a medical device innovator and manufacturer, we take quality very seriously and we are very pleased with the recognition that ISO 13485 certification provides.”

The innovative Macy Catheter is the only device designed solely for ongoing rectal delivery of medications and fluids.  It offers clinicians and caregivers an easy, discreet, and comfortable alternative to oral or intravenous (IV) administration in a variety of settings when patients are unable to swallow.  The Macy Catheter received Food and Drug Administration (FDA) clearance in 2014 and is being used by hospice and palliative care organizations throughout the United States.  More recently, published research has demonstrated that the Macy Catheter can be effectively used in the emergency room and intensive care unit settings.

“While we focus our direct commercial efforts in the United States, we look forward to working with distribution partners in Europe and other markets where the CE mark is required,” said Ladabaum.

Hospi Corporation
www.hospicorp.com

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