UK preparing for ‘worst-case’ medical supply Brexit plan

Brexit

The UK government is preparing for a “worst-case” Brexit scenario in which no deal is reached between the country and the European Union by March 29, the date the country is slated to leave the EU, according to a recent release from UK health minister Matt Hancock.

Preparations include increasing the stock holding capacity in the country and beginning to stockpile medical supplies to address possible border delays that may result from a ‘no deal’ exit. Efforts are also underway to develop measures to “allow continued movement of products into the UK from the EU at short notice,” according to the release.

Border delays could last as long as six months, Hancock warns, saying that there will be “significantly reduced access across short straits,” with impacts most likely to be felt in crossings into Dover and Folkestone.

“This is very much a worst-case scenario. In a ‘no deal’ exit from the EU we would, of course, be pressing member states hard to introduce pragmatic arrangements to ensure the continued full flow of goods which would be to their benefit as well as ours. Nevertheless, as a responsible Government, we have a duty to plan for all scenarios. And in areas where we cannot tolerate significant risk to the flow of goods, such as with medicines and medical products, we need to have contingency plans in place for this worst-case planning assumption,” Hancock wrote in the release. “The Government recognizes the vital importance of medicines and medical products and is working to ensure that there is sufficient roll-on, roll-off freight capacity to enable these vital products to continue to move freely in to the UK. The Government has also agreed that medicines and medical products will be prioritised on these alternative routes to ensure that the flow of all these products will continue unimpeded after 29 March 2019.”

Hancock said that the Dept. of Health & Social Care has been working with industry members to shore up supply lines, and urged “any company that routinely imports products from other EU countries” that has not yet engaged with them to contact them immediately.

In August, the UK’s Medicines and Healthcare products Regulatory Agency released an update on what medtech and pharmaceutical companies can expect to see as the country begins to implement plans to split from the European Union.

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BioCardia submits bid for FDA clearance of Avance transseptal introducer

BioCardia

BioCardia (NSDQ:BCDA) said today that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The San Carlos, Calif.-based company said the Avance device uses new technology developed for the company’s Morph line of steerable introducers and applies the same technology for transseptal procedures.

BioCardia touted that the Avance introducer is intended to be virtually whipless around curves due to helically arranged pull-wires, and added that the system also offers a rotating hemostasis port.

“The best-in-class design that underlies Avance was developed to enhance delivery of our investigational CardiAMP and CardiALLO cell therapies. We are excited about making this product available to the broader transseptal market, and expect it to favorably impact revenues in the second half of 2019,” BioCardia CEO Peter Altman said in a press release.

In August, BioCardia touted data from the first 10 patients treated in its Phase III CardiAmp heart failure trial.

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Report: India still lacks solid medical device regulation

India

It has been 13 years since Indian health authorities were directed to create a framework for medical device regulation, but only 23 of 5,000 product categories are currently regulated, according to a report from the Hindu BusinessLine.

In 2005, a Chief Justice at the Bombay High Court overhearing a case involving drug-eluting stents was shocked to find out that there was no framework to regulate medical devices, and directed the Central and State regulatory bodies to create a an entity to regulate the devices, according to the report.

On January 1 this year, the Indian gov’t implemented Medical Device Rules, but the implementation fell short of a 2015 promise from the then Minister of Chemicals and Fertilizers Ananth Kumar, which oversaw medicines and devices, according to the Hindu BusinessLine.

“Devices are not medicines made from a homogeneous chemical batch with very long lifecycles but usually an assembly of precision-engineered components with an ever-evolving, innovative, short-term product lifecycle,” the Association for Indian Medical Device Industry’s Rajiv Nath said, according to the report.

Patient safety is more complicated with devices than with pharmaceuticals, Nath added, saying that it is “a shared responsibility of the manufacturer, medical practitioners, product user and the regulator,” the Hindu BusinessLine reports.

AdvaMed’s Abby Pratt echoed the need to separate medical devices from pharmaceuticals, adding that “there is no need to reinvent the wheel here,” as global benchmarks and groups exist that could help organize such a regulatory framework, according to the report.

Money may be a key factor in the lack of regulation in India, according to former Maharashtra FDA Commissioner Mahesh Zagade, the Hindu BusinessLine reports. He alleges that money prevents the system from acting in patient interest or in holding companies accountable, alongside a “lack of willingness” at the administrative and political levels.

In May, a report emerged suggesting that India has no plans to roll back it price caps on stents and in fact plans to cap the prices on a trio of other cardiac devices and intraocular lenses.

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NuVasive wins expanded FDA nod for Monolith corpectomy system

NuVasive

NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures.

The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction following corpectomy for the decompression of the spinal cord and neural tissue in cervical degenerative disorders, the San Diego-based company said.

The device was initially cleared in 2015 for use in thoracolumbar corpectomy procedures, NuVasive said. The system features a monolithic cage made from PEEK and modular endcaps for anatomical personalization.

“Expanding the indicated use of our Monolith corpectomy system to include cervical corpectomy procedures demonstrates the company’s continued commitment to expanding our cervical spine interbody portfolio. We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives,” strategy, tech & corp dev prez Matt Link said in a press release.

Last month, NuVasive said that it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures.

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FDA clears Contego Medical’s Vanguard IEP peripheral balloon

Contego Medical's Paladin balloonContego Medical said today that it won 510(k) clearance from the FDA for its Vanguard IEP peripheral balloon, which features an embolic protection function.

“Securing FDA clearance for Vanguard IEP represents a major milestone for Contego Medical,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “As the patient population with peripheral arterial disease continues to expand and become more complex, we believe our technology will play a critical role in protecting vulnerable patients from embolic events and thus improve procedural outcomes.”

“The Vanguard IEP System is designed to protect patients at high risk for embolization during peripheral angioplasty, such as those with acute limb ischemia, severe calcification, and chronic total occlusions if crossed intraluminally. It is also well suited to protect patients at high risk for complications should embolization occur, such as those with poor distal run-off,” added Dr. Thomas Zeller, of Bad-Krozingen, Germany’s Unversitaets Herzzentrum, and principal investigator of Contego’s Entrap study. “In our experience, the device has performed exactly as intended and we are impressed with the ease of use of the system, with no more exchanges required than in a typical angioplasty procedure.”

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Meril Life Sciences wins approval for TAVR in India

Meril Life Sciences’ MyVal TAVR device

Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report.

The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells offer high radial strength, according to the company’s website.

India’s Central Drugs Standard Control Organisation granted the MyVal device approval for commercialization last month, according to a report on moneycontrol.com. In addition to the valve, Meril (Vapi, Gujarat, India) developed the entire minimally invasive technology to place it in the heart, the report says.

“All patients are doing well post procedure and during follow-up,” the company said in a statement reported by MoneyControl. “This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure which is an important benefit for the patient already treated for valve replacement.”

Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) dominate the TAVR industry. In October, Edwards (Irvine, Calif.) launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The previous month, Fridley, Minn.-based Medtronic announced the launch of a study of its CoreValve Evolut replacement heart valve in a low-risk patient population with a genetic form of heart disease, following a pair of FDA decisions about the treatment.

 

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What is the future of medtech in 2019?

future of medtech medical device predictions crystal ball

[Image from Unsplash]

A global push to increase medical device industry regulation and the continued blurring of high tech and medtech – those are but some of the predictions that Medical Design & Outsourcing editors are hearing from experts.

Read on to discover some of the top predictions of where the industry is going in 2019.

Next>>

Senior editor Nancy Crotti and assistant editor Danielle Kirsh contributed to this report. 

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Olympus wins FDA nod for Spiration bronchial valve

Olympus

Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device.

The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during a bronchoscopic procedure to reduce lung volume in diseased lung sections and allow healthier tissue in the remaining portion of the lung to function better.

Approval of the device came based on the results from the Emprove clinical trial of the SVS, which demonstrated that patients treated with the system showed statistically significant and clinically meaningful improvements in lung function and quality of life as compared to the standard of care.

Results also indicated a favorable risk benefit profile and a shortened procedure time, which Olympus said may reduce the risk of adverse events. Serious adverse events noted in the study included chronic obstructive pulmonary disorder exacerbations, air leaks, pneumonia and death.

“In the patients I treated in the Emprove trial, the most important outcome was a marked reduction in shortness of breath, or dyspnea. This resulted in improved quality of life and patient satisfaction. Dyspnea is the most common symptom in patients with advanced emphysema and severe hyperinflation, and is the most refractory to medical treatment,” Dr. Gerard Criner of the Lewis Katz School of Medicine at  Temple University said in a press release.

In October, Olympus said that it launched the Endoeye Flex 3D and FlexDex needle driver laparoscopic surgical tools in the U.S.

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FDA warns Globus subsidiary HBT over ViaCell production facility issues

Globus Medical

The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April.

The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues.

In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away from the agency’s core current good tissue practice requirements.

“For example, since the start of ViaCell processing in October 2016 through August 2017, you have had monthly sterility failure rates of [redacted] during seven of those months, with one month having a sterility failure rate of [redacted]. Your firm failed to conduct an investigation of all these sterility failures to determine the cause. You also failed to investigate additional sterility failures that occurred from October 2017 through February 2018. By neglecting to identify the cause of the sterility failures, you also failed to take appropriate corrective action(s) to prevent recurrence of the failures,” the FDA wrote in its letter.

The agency also noted a failure to “validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests,” according go the FDA notice. The example provided again related to the facility’s ViaCell manufacturing process.

The federal watchdog said that it has received two responses from the company so far this year, but outlined some “comments and concerns” in relation to their corrective actions.

The FDA said that it received a response in May outlining corrective actions, but voiced concerns that the actions mostly focus on sterility testing which it said were not reliable, and did not address validation issues with the ViaCell manufacturing process. The agency also noted that while the company reported a decrease in sterility failure rate, it did not discuss plans to “determine the cause of the sterility failures” or why the rate of failures was so high.

The federal watchdog also posted a response to a letter received in September with concerns over the company’s corrective steps.

In its response, Globus’ HBT subsidiary said that it launched additional validation activities covering ViaCell production in May, but the FDA stated that its concerns about the firm’s validation of the ViaCell production process remain.

The agency noted a number of issues it has with the company’s corrective process, including another noted reliance on sterility testing and concerns over possible contamination during processing.

“A disinfection or sterilization process must be validated based on the capability of that process to reduce or eliminate an expected level and mix of microorganisms on the particular product that will be put through the process. Thus, you should carefully consider the capability of your microbiological testing, disinfection, and sterilization processes when you evaluate pre-processing cultures to determine whether or not the HCT/Ps should be processed,” the FDA wrote in its notice.

The FDA also knocked the company on not excluding or discarding samples from donors positive for Clostridium, Streptococcus pyogenes or “any other microorganism that you have determined to be difficult to eliminate, unless you have a terminal sterilization process validated to a sterility assurance level of 10-6.”

In its last point, the agency referenced a lack of positive results from all environmental and personnel monitoring sample testing, saying that having producing no positives is “highly unusual, especially when your sterility failure rates were so high.”

“We strongly suggest you review your environmental monitoring program to ensure that it is capable of detecting microorganisms in your environment and on your personnel,” the federal watchdog wrote.

The FDA gave the company 15 working days to respond to the issues.

Last month, Globus Medical posted third quarter earnings that handily topped expectations from analysts on Wall Street.

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FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator

Impulse Dynamics

The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report.

The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility modulation – non-excitatory electrical pulses delivered to the heart muscle. The system has had CE Mark approval in the European Union for the device since 2002.

The FDA’s Circulatory Systems Device Panel voted 12 to 1 in favor of the device’s safety and 11 to 2 in favor of its efficacy, according to Healio. The panel also voted 12 to 0, with a single abstention, that benefits of the device outweighed the risks.

The device came supported by safety and efficacy evidence from the 418-patient FIX-HF-5 study of the device, which compared treatment with CCM to guideline-directed medical therapy for heart failure patients, according to the report.

The trial’s primary safety endpoint was defined as a composite event rate of all-cause hospitalizations and all-cause mortality through 50 weeks, which was reported at 4.9% in the CCM treatment arm and 3.3% in the control arm, according to Healio. No deaths were reported as caused by the implant procedure or the device, and rates of events that required invasive treatment or hospitalization were balanced between groups.

The primary effectiveness endpoint of the trial, defined as the difference in responder rates between the CCM and control groups, was reported at 5.9%, with a 17.6% rate in the CCM arm and 11.7% in the control group. The difference was not reported as being statistically significant.

The system was also supported by data from the 160-patient FIX-HF-5C study which had a similar patient population to the FIX-HF-5 study, according to Healio.

The primary safety endpoint in the second trial was defined as the percentage of CCM patients who experienced either device- or procedure-related complications through 24 weeks. Results indicated that 90% of CCM patients were free from complications at follow-up, according to the report.

The primary effectiveness endpoint in the trial was the mean difference in peak VO2 between the CCM and control arms at 24 weeks. Investigators included data from nearly 30% of patients from the FIX-HF-5C study for assessing the endpoint, Healio reports. With imputation of zeroes performed to account for six deaths, peak VO2 was 14.21 ml/kg/min for the control arm vs 15.04 ml/kg/min for the CCM arm, from baseline VO2 levels of 15.4 ml/kg/min.

A registry for a post-approval study was proposed that will seek to collect data from 300 patients for two years, with a similar format to left atrial appendage occlusion and transcatheter aortic valve replacement registries, according to the report. Investigators in the study plan to review all-cause mortality and 1- and 2-year mortality assessments as compared with the Seattle Heart Failure Model scoring system.

The company won a date with an FDA panel in October. Last May, Impulse Dynamics said that it closed a $45 million equity financing round to support its CCM tech.

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