Egypt fast-track medical device registration pathway speeds up market access timeframes

Emergo GroupBy Stewart Eisenhart, Emergo Group

A fast-track premarket review pathway for some medical devices in Egypt is yielding substantially reduced time to market for qualifying manufacturers.

Get the full story here at the Emergo Group’s blog.

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

Glaukos touts 5-year study of glaucoma stents

Glaukos  (NYSE:GKOS) said today that a study of its iStent trabecular micro-bypass stents reduced eye pressure in glaucoma patients five years after implant. The same study showed that significantly fewer iStent patients needed add-on medications after five years, the company said.

The study showed that newly diagnosed, primary open-angle glaucoma (POAG) patients who received two iStents achieved a 35.3% reduction in mean intraocular pressure (IOP) to 16.5 mmHg. The prospective, controlled, multi-surgeon clinical trial pitted evaluated the five-year safety and efficacy of two iStents vs. topical prostaglandin as an initial intervention in POAG subjects who had not had prior glaucoma treatment. A total of 101 subjects were randomized in a 1:1 ratio to receive either two iStents in a standalone procedure or once-daily topical travoprost, a commonly prescribed prostaglandin. The results were published in Ophthalmology Glaucoma.

Treatment success — defined as mean diurnal IOP of 6 mmHg to 18 mmHg without add-on medication or secondary glaucoma surgery — was achieved in 77% of stent eyes vs. 53% of travoprost eyes (p = 0.04). Seventeen percent of stent eyes vs. 44% of travoprost eyes required add-on medication.

The need for add-on medication arose at a slower rate in the stent group than in the travoprost group, especially after two years of follow-up. Study authors observed that from two to five years of follow-up, add-on medications were initiated in roughly double the number of travoprost eyes vs. stent eyes. The safety profile was excellent in both groups throughout follow-up, according to the San Clemente, Calif.-based company.

“Topical ocular hypotensive medications are typical first-line glaucoma therapy but these drugs can be ineffective due to high rates of patient non-adherence, ocular surface damage, cost and other factors,” said ophthalmic surgeon and lead author Dr. Robert Fechtner in a prepared statement from Glaukos. “This study shows that not only are Glaukos’ iStents as effective as once-daily topical travoprost in controlling IOP, but they also succeed at maintaining IOP reductions over the long-term with fewer additional medications.”

Three-year outcomes of this study were published in 2016 in Ophthalmology and Therapy. The most recent article detailing five-year outcomes may be accessed online here.

“This latest publication represents the first-ever five-year, protocol-driven, randomized evaluation of standalone iStent implantation in newly diagnosed glaucoma patients,” said Glaukos prez & CEO Thomas Burns. “Moreover, it adds meaningful outcomes data to the growing body of peer-reviewed evidence that implantation of a single or multiple iStents can reliably achieve sustained IOP reductions in an elegant, tissue-sparing procedure with a highly favorable safety profile.”

Today’s announcement was good news for Glaukos, whose iStent recently fared worse in a two-year study that compared it to competitor Ivantis’ Hydrus Microstent. The Ivantis study touted reductions in medication use and no reoperations for patients in the Hydrus arm.

 

 

 

U.K. government requests Brexit deadline extension

Emergo GroupBy Ronald Boumans, Emergo Group

The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching.

Get the full story here at the Emergo Group’s blog.

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

EO plant shutdown leads to pediatric breathing tube shortage

Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)

The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.

The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered the shutdown of the Sterigenics plant in Willowbrook, Ill. due to emissions of EO, a highly carcinogenic chemical compound.

Get the full story on our sister site, Medical Design & Outsourcing.

Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown

Emergo GroupBy Stewart Eisenhart, Emergo Group

Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019.

Get the full story here at the Emergo Group’s blog.

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

5 digital health startups you need to watch in 2019

(Image from Unsplash)

Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).

Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most funding of any function in 2018, $3 billion across 193 deals.

Here are five of the up-and-coming digital health companies to watch in 2019:

Get the full story on our sister site, Medical Design & Outsourcing.

5 issues for medical device risk management and design controls

Emergo GroupBy Mark Leimbeck, Emergo Group

Medical device design and development processes in the context of risk management require careful consideration and planning by manufacturers. Following our webinar in early 2019, we explore five key issues companies face when linking design and development with risk management and, ultimately, patient safety.

Get the full story here at the Emergo Group’s blog.

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

FDA identifies hundreds of device types affected by sterilization facility closures

Emergo GroupBy Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year.

Get the full story here at the Emergo Group’s blog.

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

The Nuremberg Code and its impact on clinical research

imarcby Natalie Jarmusik, Clinical Research Associate, IMARC Research

The Nuremberg Code is one of the most influential documents in the history of clinical research.

Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects.

We’ll take a closer look at its origins, its guidelines and its enduring impact.

What Is the Nuremberg Code?

When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945.  As part of the Tribunal, a series of trials were held against major war criminals and Nazi sympathizers holding leadership positions in political, military, and economic areas.  The first trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious experiments they carried out on unwilling prisoners of war.  Many of the grotesque medical experiments took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after death.

The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was conducted at the Palace of Justice in Nuremberg, Bavaria, Germany.  The trial was conducted here because this was one of the few largely undamaged buildings that remained intact from extensive Allied bombing during the war.  It is also said to have been symbolically chosen because it was the ceremonial birthplace of the Nazi Party.  Of the 23 defendants, 16 were found guilty, of which seven received death sentences and nine received prison sentences ranging from 10 years to life imprisonment. The other 7 defendants were acquitted.

The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for human experimentation.

What Are The Nuremberg Code’s Ethical Guidelines For Research?

The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are:

  1. Voluntary consent is essential
  2. The results of any experiment must be for the greater good of society
  3. Human experiments should be based on previous animal experimentation
  4. Experiments should be conducted by avoiding physical/mental suffering and injury
  5. No experiments should be conducted if it is believed to cause death/disability
  6. The risks should never exceed the benefits
  7. Adequate facilities should be used to protect subjects
  8. Experiments should be conducted only by qualified scientists
  9. Subjects should be able to end their participation at any time
  10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur

Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

The Significance Of The Nuremberg Code

The Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP).

Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts, ideas and lessons learned throughout the history of clinical research worldwide.

Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule.

Although there has been updated guidance to Good Clinical Practice to reflect new trends and technologies, such as electronic signatures, these basic principles remain the same. The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects.

Japan increases medical device registration fees

Emergo GroupBy Stewart Eisenhart, Emergo Group

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.

Get the full story here at the Emergo Group’s blog.

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