pSivida touts pilot osteoarthritis trial for Durasert implant

Share

pSividapSivida (NSDQ:PSDV) touted results today from a Phase I safety and efficacy pilot trial of its sustained-release Durasert implant in patients with osteoarthritis of the knee.

The company’s Durasert tech, combined with an implantable device from the Hospital for Special Surgery, was designed to continuously deliver a low dose of dexamethasone into the knee joint. Six patients with osteoarthritis of the knee were followed throughout the study for six months.

Get the full story at our sister site, Drug Delivery Business News.

CytoSorbents wins German gov’t funding for CytoSorb endocarditis trial

Share

Cytosorbents

CytoSorbents (OTC:CTSO) said this week it won funding from the German Federal Ministry of Education and Research for a randomized controlled trial exploring the use of its CytoSorb blood purification technology for treating infective endocarditis.

The newly funded randomized, controlled, multi-center Remove trial aims to enroll 250 patients to explore the safety and efficacy of intraoperative CytoSorb in patients with dangerous bacterial heart valve infections during valve replacement surgeries and cardiopulmonary bypass procedures, the Monmouth, N.J.-based company said.

The study’s goal is to demonstrate improved hemodynamic stability and reduced organ injury, primarily measured by change in the sequential organ failure assessment score, with secondary endpoints of 30-day mortality, need for supportive care therapies and length of intensive care and in-hospital stays.

“We are very grateful to the German government for their commitment to fund the Remove trial in its entirety, and to Prof. Dr. med. Frank Brunkhorst, the Center for Clinical Studies Jena, and Jena University Hospital for sponsoring the study.  Infective endocarditis, or infection of a heart valve, can destroy the valve in hours to days, and can rapidly lead to emergency open heart valve replacement surgery in very sick patients that suffer from both sepsis and heart failure.  Patients are often unstable before, during, and after the surgery, and are prone to a high risk of complications and death, as well as a costly and lengthy hospital stay.  This is a rapidly growing problem, driven by the aging population and the opioid crisis, where the use of dirty needles by intravenous drug abusers can lead to seeding of bacteria in the bloodstream and heart valve infection,” CEO Dr. Phillip Chan said in a prepared statement.

CytoSorbents expects the trial to begin early next year, in collaboration with Thermo Fisher Scientific’s B.R.A.H.M.S and the Fraunhofer Institute for Interfacial Engineering and Biotechnology.

“This announcement of funding and collaboration follows our previous press release on October 19, 2017 highlighting the largest published endocarditis case series to date, where the intraoperative use of CytoSorb during emergent and urgent valve replacement surgery helped to improve hemodynamic stability, reduce the need for vasopressors, and was associated with a reduction of in-hospital mortality compared to a historical control.  We believe that similar results could be seen in the Remove trial.  Interestingly, the Remove study will parallel our Refresh 2 pivotal, registration trial in the U.S., designed to support FDA regulatory approval.  The Refresh 2 trial will also focus on the intraoperative use of CytoSorb during valve replacement surgery – but specifically excludes infective endocarditis – to reduce the incidence or severity of post-operative organ dysfunction. If successful, the two trials could rapidly lead to the use of CytoSorb as standard of care in most, if not all, open heart valve replacement surgeries, which accounts for hundreds of thousands of procedures worldwide,” CEO Dr. Chan said in a press release.

In May, CytoSorbents presented results from the Refresh trial of its CytoSorb blood purification tech, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study

Share

PQ Bypass

PQ Bypass said today it won FDA investigational device exemption approval to launch a pivotal clinical trial of its Detour percutaneous femoropopliteal bypass system designed to treat patients with peripheral artery disease.

The company’s Detour II clinical trial will look to enroll up to 292 patients with lower limb ischemia due to long blockages over 15 cm in the superficial femoral artery, the Sunnyvale, Calif.-based company said.

“We worked closely with the FDA, leading physicians and healthcare administrators to design a trial that we expect to demonstrate the total value of this unique approach to treating severe PAD. Detour II is an exciting milestone in the journey toward establishing a potentially transformative future standard of care for these patients,” PQ Bypass board chair Richard Ferrari said in a press release.

The Detour procedure is designed around the company’s Detour system which includes a Torus stent graft, Detour crossing device and Detour snare. The procedure creates a pathway originating in the SFA and traveling through the femoral vein to end in the popliteal artery, bypassing parts of the artery affected by disease.

The Torus stent grafts are designed to be placed in a continuous line to re-direct blood around the blockage and restore blood flow to the lower leg and foot in patients, the company said.

“The Detour System features a truly innovative, intuitive design and the trial will investigate its benefits in addressing long lesions that are not well served by existing minimally-invasive approaches. We look forward to working with the Detour II Trial clinical sites on this important research,” Detour II trial co-principal investigator Dr. Jihad Mustapha of the Michigan State University College of Osteopathic Medicine said in a prepared release.

The prospective, single-arm, multi-center trial will engage with patients at up to 40 sites to analyze safety and effectiveness data of the Detour system as the company seeks FDA pre-market approval. The trial will also include a prospective economic study to collect data related to costs associated with treating PAD.

“Patients with life-limiting claudication or critical limb ischemia typically have lesions longer than 15 cm, and we know that lesion length is directly proportional to patency. Until now, endovascular methods of treating these long lesions have not been comparable to open bypass surgery. The Detour procedure is designed to treat patients with severely calcified or long-segment disease. It’s essentially a femoropopliteal bypass with polytetrafluoroethylene, but done percutaneously. The Detour I trial in Europe demonstrated safety and efficacy in patients with lesions as long as 44 centimeters in length, and we look forward to continuing to study this procedure with the commencement of Detour II,” Detour II trial co-principal investigator Dr. Sean Lyden of the Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute said in a prepared statement.

In September, PQ Bypass released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days.

Study: Catheter thrombolysis doesn’t lower risk of post-thrombotic syndrome, raises bleeding risk

Share

thrombolysisA study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding.

The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm was treated with the intra-thrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting. The primary outcome was development of PTS between 6 and 24 months.

The researchers found no significant difference between the groups in terms of PTS, which was found in 47% of the experimental cohort and in 48% of the control group. But there were more major bleeding events in the interventional arm within 10 days (1.7% vs. 0.3%).

However, there were no significant differences in recurrent venous thromboembolism over two yaers, with 12% occurring in the pharmaco-mechanical-thrombolysis group and 8% in the control group. Moderate-to-severe PTS occurred in 18% of patients in the treatment arm versus 24% in the control group.

Severity scores for PTS were lower in the interventional group than in the control group at 6, 12, 18, and 24 months, but “the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups,” the study found.

“Among patients with acute proximal deep-vein thrombosis, the addition of pharmaco-mechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding,” the authors wrote.

Mixed migraine results for PFO closure study

Share

St. Jude MedicalPercutaneous closure of patent foramen ovale did not significantly lessen the frequency of migraines in patients with episodic migraines, according to a study published yesterday in the Journal of the American College of Cardiology. 

Although the Premium trial missed its primary endpoint, the study met the secondary endpoint of reducing migraine days after PFO closure.

A sub-group analysis also found that patients with frequent aura experienced a significant reduction in migraine attacks with PFO closure. One of the trial’s investigators told Medscape that there is validity to right-to-left shunt closure, as long as researchers can identify the subset of patients who are most likely to respond.

The 230-patient trial focused on patients with six to 14 migraine days per month. The participants also had failed at least three migraine preventive medications and showed significant right-to-left shunt in ultrasonography scans. Researchers randomized patients to receive medication with a sham procedure or medication and PFO with St. Jude Medical‘s Amplatzer PFO Occluder.

The primary efficacy endpoint was met in 45 of 117 patients in the PFO group and 33 of 103 patients in the control group. Data from the study also showed that 10 patients in the PFO group experienced complete cessation of migraine attacks for one year compared to one patient in the control group.

Patients in the PFO group had 3.4 fewer migraine days per month compared to baseline, while participants in the control group had two fewer migraine days per month.

Although previous work has shown an association between patients with migraines and the presence of PFO, there is still an ongoing debate whether PFO closure can lessen the frequency of migraine attacks. The mixed results of the Premium trial underscore that debate and some see it as highlighting the need to focus PFO-closure trials on patients with frequent aura.

In a subgroup analysis of patients with aura as a consistent feature of their migraines, 49% of patients in the PFO group saw a >50% reduction in migraine days compared to 23% of patients in the control group.

“Because this subgroup was not prespecified, these observations can be used only to generate the hypothesis that a future clinical trial of PFO closure might be beneficial in subjects where aura is a frequent component (>50%) of the migraine episodes,” the researchers wrote.

Lumicell aims $29m Series C at pivotal breast cancer trial and expansion into other cancers

Share

LumicellWith $28.7 million from a recently-closed Series C round, Lumicell reported today that it plans to launch a pivotal trial of its image-guided cancer surgery tech in breast cancer.

The Wellesley, Mass.-based company added that it hopes to expand its clinical program into other solid tumor cancers, including lung, ovarian and brain cancer.

Get the full story at our sister site, Drug Delivery Business News.

Titan Medical installs 3rd, final Sport system for validation & feasibility trials

  • Solvay releases new PEEK polymer for implantable devices

    Solvay has launched its new Zeniva ZA-600 CF30 polyetheretherketone (PEEK) designed for use in implantable device applications. Zeniva ZA-600 CF30 PEEK is a 30% carbon fiber-reinforced, radiolucent polymer that offers modulus that is similar to cortical bone. The polymer helps implants minimize bone density reduction while maintaining normal stress on surrounding bone tissues. The polymer […]

  • Lexington Biosciences moves forward with its affordable heart diagnostic device

    Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device. The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial […]

  • Tobii and RightEye partner to create eye-tracking system

    RightEye and Tobii announced that they have forged a partnership to develop new hardware solutions for RightEye vision tests and training games for healthcare, vision and sports markets. “We’re excited to be partnering with Tobii to advance our product and offer customers a more portable, integrated eye-tracking system to further enhance their users’ experience with […]

  • How Smith & Nephew’s InVentures program is promoting innovation

    For nearly a decade, Smith & Nephew’s InVentures program has worked with surgeons who have innovative ideas but aren’t starting their own companies. The program provides a third innovation route on top of the major two for big medical device companies: internal R&D and acquisition of smaller companies with new technologies. “A company the size of Smith […]

  • Promenade Software to showcase medical device software at DeviceTalks West

    Promenade Software is a company comprised of highly skilled and experienced medical device software engineers with expertise spanning from low-level firmware to embedded applications, mobile applications and cloud services. Its engineers are on-site in Irvine, Calif. Featured technology and services: Parlay, professional services, cybersecurity Parlay: Parlay accelerates the development of medical device software, while simultaneously enabling testing and […]

  • Zeiss launches new imaging software

    Zeiss has launched its newest imaging software called the Zeiss Zen 2 core for improving laboratory workflow and efficiency. Zeiss Zen 2 core is a lab infrastructure solution designed to connect systems, data and workflows, helping laboratories become more efficient. The imaging software is used as a tool for image analysis and interactive control of […]

  • Overmolding: 2 types to know

    MTD Micromolding Some micro projects require specialty micro injection molding processes, such as overmolding. Overmolding involves two or more materials molded together to become one part. Examples include molding plastic over plastic or molding plastic over a preformed part, such as a metal insert. (See examples of common polymers and substrates below.) MTD specializes in […]

  • 3D printed organ models are getting way better: Here’s how

    University of Minnesota researchers are taking 3D printed organ models to the next level: They look and feel like the real thing, and integrated sensors help surgeons train. There’s even the potential that such artificial models may someday become the real deal – “bionic organs” used to replace damaged biological organs. The Minnesota researchers published […]

  • How BioSig is using plug and play as a medtech startup strategy

    Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during […]

  • PEEK formulations for new implantable devices

    Since the late 1990s, polyether ether ketone has become a go-to material for companies that manufacture orthopedic implants, thanks to its radiolucency and anatomical properties. Now, custom formulations of PEEK are enabling new potential applications for the polymer. Lawrence Acquarulo, Foster Corp. Polymers have always played a role in modern implantable medical devices. But until […]

  • Materialise and Formlabs want to bring more 3D printing labs to hospitals

    Materialise (Leuven, Belgium) and Formlabs (Somerville, Mass.) have forged a partnership to help deliver cost-effective solutions to hospitals that want to start in-house 3D printing labs. The partnership combines Materialise’s Mimics inPrint medical imaging software with Formlabs’s Form 2 printers to create a complete 3D printing package that will help implement patient-specific care that is an affordable price-per-print. Using […]

  • Nemaura Medical touts precision data for non-invasive glucose monitor

  • Solvay releases new PEEK polymer for implantable devices

    Solvay has launched its new Zeniva ZA-600 CF30 polyetheretherketone (PEEK) designed for use in implantable device applications. Zeniva ZA-600 CF30 PEEK is a 30% carbon fiber-reinforced, radiolucent polymer that offers modulus that is similar to cortical bone. The polymer helps implants minimize bone density reduction while maintaining normal stress on surrounding bone tissues. The polymer […]

  • Lexington Biosciences moves forward with its affordable heart diagnostic device

    Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device. The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial […]

  • Tobii and RightEye partner to create eye-tracking system

    RightEye and Tobii announced that they have forged a partnership to develop new hardware solutions for RightEye vision tests and training games for healthcare, vision and sports markets. “We’re excited to be partnering with Tobii to advance our product and offer customers a more portable, integrated eye-tracking system to further enhance their users’ experience with […]

  • How Smith & Nephew’s InVentures program is promoting innovation

    For nearly a decade, Smith & Nephew’s InVentures program has worked with surgeons who have innovative ideas but aren’t starting their own companies. The program provides a third innovation route on top of the major two for big medical device companies: internal R&D and acquisition of smaller companies with new technologies. “A company the size of Smith […]

  • Promenade Software to showcase medical device software at DeviceTalks West

    Promenade Software is a company comprised of highly skilled and experienced medical device software engineers with expertise spanning from low-level firmware to embedded applications, mobile applications and cloud services. Its engineers are on-site in Irvine, Calif. Featured technology and services: Parlay, professional services, cybersecurity Parlay: Parlay accelerates the development of medical device software, while simultaneously enabling testing and […]

  • Zeiss launches new imaging software

    Zeiss has launched its newest imaging software called the Zeiss Zen 2 core for improving laboratory workflow and efficiency. Zeiss Zen 2 core is a lab infrastructure solution designed to connect systems, data and workflows, helping laboratories become more efficient. The imaging software is used as a tool for image analysis and interactive control of […]

  • Overmolding: 2 types to know

    MTD Micromolding Some micro projects require specialty micro injection molding processes, such as overmolding. Overmolding involves two or more materials molded together to become one part. Examples include molding plastic over plastic or molding plastic over a preformed part, such as a metal insert. (See examples of common polymers and substrates below.) MTD specializes in […]

  • 3D printed organ models are getting way better: Here’s how

    University of Minnesota researchers are taking 3D printed organ models to the next level: They look and feel like the real thing, and integrated sensors help surgeons train. There’s even the potential that such artificial models may someday become the real deal – “bionic organs” used to replace damaged biological organs. The Minnesota researchers published […]

  • How BioSig is using plug and play as a medtech startup strategy

    Startups, as a rule, should have a plan for their technology to grow. But it is rare that a medical technology startup aims to be plug and play, fitting into many therapeutic areas from cardio to Alzheimer’s to diabetes. BioSig’s Pure EP, an electrophysiology signal recording and processing system, could potentially provide valuable insight during […]

  • PEEK formulations for new implantable devices

    Since the late 1990s, polyether ether ketone has become a go-to material for companies that manufacture orthopedic implants, thanks to its radiolucency and anatomical properties. Now, custom formulations of PEEK are enabling new potential applications for the polymer. Lawrence Acquarulo, Foster Corp. Polymers have always played a role in modern implantable medical devices. But until […]

  • Materialise and Formlabs want to bring more 3D printing labs to hospitals

    Materialise (Leuven, Belgium) and Formlabs (Somerville, Mass.) have forged a partnership to help deliver cost-effective solutions to hospitals that want to start in-house 3D printing labs. The partnership combines Materialise’s Mimics inPrint medical imaging software with Formlabs’s Form 2 printers to create a complete 3D printing package that will help implement patient-specific care that is an affordable price-per-print. Using […]

  • InspireMD touts 2-year CGuard EPS results

    Share

    InspireMD

    InspireMD (NYSE:NSPR) this week released two-year results from the Paradigm 101 clinical study of its CGuard embolic protection system.

    Results from the trial were initially presented at the 2017 VEITH Symposium in New York last month.

    In the investigator-led study, researchers examined the use of the CGuard EPS system in 101 patients with symptomatic or high-risk asymptomatic carotid artery stenosis. Data from the study indicated that there were no deaths, major stroke or myocardial infarctions as a result of periprocedural or postprocedural interventions at at two years.

    InspireMD said that the results were consistent with other CGuard EPS trials including the Carenet, Iron-Guard, Wissgott and Casana studies.

    “We are excited to see Prof. Musialek’s report out on the long-term follow-up data from the Paradigm study, which represents the longest known clinical follow-up with any such carotid devices to date. This is just another piece of data that continues to reinforce the potential benefits of CGuard EPS. The 24 month follow-up data from this trial simply confirms the sustained long term benefit CGuard could provide to patients with carotid artery disease,” CEO James Barry said in a press release.

    In October, InspireMD touted an independent clinical trial in Russia pitting its CGuard embolic protection device against the Rx Acculink carotid stent made by Abbott (NYSE:ABT).

    Insightec wins FDA nod for Exablate Neuro glioblastoma trial

    Share

    Insightec

    Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma.

    The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

    In the trial, a research team will inject commonly used a sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor, after which ultrasound will be used to oscillate the microbubbles to cause temporary disruption of the blood brain barrier.

    “Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology. Insightec continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most – patient lives,” CEO & chair Dr. Maurice Ferré said in a press release.

    The study is set to enroll up to 15 subjects with suspected glioblastoma who are scheduled to undergo a tumor resection, with Dr. Graeme Woodworth of the University of Maryland School of Medicine acting as principal investigator.

    Last month, Insightec said it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease.