Showing all posts written by Marissa Calcagno

Marissa Calcagno
Like: Using Virtual Reality to Provide Better Treatment for Patients

Like: Using Virtual Reality to Provide Better Treatment for Patients

Facebook previously announced its $2 billion acquisition of Oculus VR, Inc.  The announcement touts Oculus as being “the leader in immersive virtual reality technology,” having built “strong interest among developers” for its virtual reality (VR) headset, the Oculus Rift.  The press release also reports that “Facebook plans to extend Oculus’ existing advantage in gaming to new verticals, including communications, media and entertainment, education and other areas.”


What if the “other areas” include applications of virtual reality in the healthcare field? 

Renal Denervation in the Wake of the Recent Medtronic Trial Results

Renal Denervation in the Wake of the Recent Medtronic Trial Results

According to the Mayo Clinic, percutaneous renal artery sympathetic denervation (“RDN”) is a procedure used to perform circumferential radiofrequency ablation of the renal arteries.  Percutaneous renal artery sympathetic denervation has already been used on patients with resistant hypertension in clinical trials and later in clinical practice in Europe.  While RDN remains investigational in the United States, Medtronic and St. Jude Medical have the SymplicityTM and EnligHTN devices, respectively, which are CE mark approved in Europe and are in clinical trials in the U.S.  Other device makers with CE-mark approved RDN devices include Covidien, which acquired Maya Medical in 2012 for $60 million; Boston Scientific, which acquired Vessix Vascular in 2012 for $425 million; ReCor; and Terumo.  An October 2013 report on Market Realist  states that analysts estimate that the global RDN market will increase at a compound annual growth rate of 42% from 2012 to 2016.


According to Medtronic’s website, Medtronic’s SymplicityTM RDN system consists of a catheter and a  generator.  The SymplicityTM catheter is placed in the vasculature adjacent to the target neural site and delivers radiofrequency energy to the target nerves. The radiofrequency energy is delivered to the SymplicityTM catheter from the SymplicityTM generator.

On January 14, 2014, Medtronic announced that its U.S. pivotal trial in renal denervation for treatment-resistent hypertension, SYMPLICITY HTN-3, failed to meet its primary efficacy endpoint.  According to Medtronic’s press release, its U.S. pivotal trial was the first blinded, randomized, controlled trial.  Although the trial met its primary safety endpoint, it failed to meet its primary efficacy endpoint.  As a result, Medtronic will convene a panel of independent advisors to make recommendations about the future of Medtronic’s global hypertension clinical trial program.  Pending this review, Medtronic says that it plans to suspend enrollment in ongoing clinical trials in the U.S. (SYMPLICITY HTN-4), Japan (HTN-Japan), and India (HTN-India), and begin to inform clinical trial sites, clinical trial investigators, global regulatory bodies, and customers of these findings and decisions.  Medtronic also says it intends to ensure patient access to the SymplicityTM technology at the discretion of their physicians in markets where it is approved. Additionally, Medtronic states that intends to continue the global SYMPLICITY post-market surveillance registry and renal denervation studies on other non-hypertension indications.


On January 21 Covidien announced that it will exit its OneShot™ Rendal Denervation Program.  According to its press release, its decision is primarily in response to slower than expected development of the renal denervation market.  As a result, Covidien reports that it will not proceed with its RAPID II randomized study and expects to record after-tax charges from $20 to $25 million as a result of exiting its OneShot™ program.


Federal Circuit Affirms Rejection of Claims Directed to a System for Detection of Blood Within a Body Lumen

Federal Circuit Affirms Rejection of Claims Directed to a System for Detection of Blood Within a Body Lumen

On July 19, the Federal Circuit affirmed a decision of the Board of Patent Appeals and Interferences that the claims of U.S. Patent Application No. 10/097,096 were obvious over a combination of prior art references.  The ‘096 application states that it relates to “a method and system for detection of colorimetric abnormalities in vivo, and specifically within the gastrointestinal (GI) tract.” Figure 3 of the ‘096 application is shown below:

The Federal Circuit held that the Board’s affirmance of the Examiner’s rejection of all claims as obvious was “supported by substantial evidence.” The Federal Circuit found that the claims at issue were a “predictable variation of the combination of [the prior art references].” The Federal Circuit also rejected the Applicant’s argument that the Board relied on new grounds in reaching its decision, stating: “[w]hile the Board’s explanation may go into more detail than the examiner’s, that does not amount to a new ground of rejection.”

Fighting Fire with Fire – the Medical Device Tax and Outsourcing

Fighting Fire with Fire – the Medical Device Tax and Outsourcing

Since its passage as part of the Affordable Care Act in 2010, the medical device tax has been hotly debated.  The 2.3% excise levied on total revenues may effectively preclude new entrants while hindering the growth of established companies.  While industries have turned to outsourcing for a number of years as a way to cut costs, the medical device industry may increasingly consider outsourcing in the coming years as a means to offset the effects of this tax.  While outsourcing may help U.S. medical device companies, it may adversely affect Americans currently working in this sector.

Supreme Court Invalidates Claims to Naturally Occurring DNA

On June 13, 2013, the Supreme Court issued a unanimous decision finding that claims to naturally occurring DNA segments were invalid under the Patent Act because DNA is a product of nature and therefore not patent eligible.  Myriad, the patentee, discovered the precise location and genetic sequence of the BRCA1 and BRCA2 genes, but did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes.

The Court also ruled that a second set of claims to complementary DNA (cDNA) sequences are patent eligible because cDNA is not naturally occurring. As a result, cDNA therefore does not present the same obstacle to patentability as naturally occurring, isolated DNA segments.

The Court expressed no opinion regarding method claims, new applications of knowledge about the BRCA1 and BRCA2 genes, or patentability of DNA in which the order of naturally occurring nucleotides has been altered, noting they are not implicated by this decision. A copy of the Supreme Court’s opinion is available here: Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398.

ResMed Announces FDA Clearance of Noninvasive Ventilation Device for COPD Treatment

ResMed announced recently that the FDA had recently cleared its home variable positive airway pressure (VPAP) device for treatment of respiratory disorders such as chronic obstructive pulmonary disease (COPD).  According to its press release, one in five patients with stage 3 or 4 COPD hospitalized for acute exacerbations are readmitted to the hospital within 30 days, but by providing better at-home care such readmissions can be avoided.  Geoff Nelson, ResMed’s Respiratory Care business unit president, states in the press release that:

Minimizing the likelihood of acute events that lead to readmissions starts at the point of discharge, sending patients home with the best tools like ResMed’s VPAP COPD to help them breathe better when their lungs have been damaged by the disease.

According to the press release, ResMed’s device customizes the breath delivered to the patient with a rapid inhalation phase and an extended exhalation phase, which can help enable better gas exchange by overcoming air trapping that is common with COPD patients.  ResMed’s press release is available here.

Senate’s Vote to Repeal Medical Device Tax – Form Over Function?

Despite the Senate’s recent vote to repeal the medical device tax by a margin of 79-20, Forbes reports that the vote will have little practical effect on medical device manufacturers, at least in the short term.  In order to abolish the tax, the article states that the loss of potential revenue from the tax, equal to over $10 billion over 10 years, would have to be completely offset by alternative revenues.  The article posits:

Is there a possibility of the medical device tax being removed (or modified) down the road?  Yes there is – but that road is much more potholed and twisted than many medical device manufacturers think.

According to the article, the 2.3% excise tax on the sales price of medical devices, which was passed as part of the Affordable Care Act, currently applies to almost any FDA-registered device intended for human use.  Because the tax can apply to “everything from MRIs to tongue depressors to ultrasounds to condoms,” the article notes the concern that many taxpayers may not realize that the law can directly affect them.  The article discusses a number of other considerations medical device manufacturers will likely face, including whether a particular company is overpaying, the potential to limit tax liability by determining the “price” of the medical device itself (as separate from bundled services), and situations involving contract manufacturers.  The full article is available here.

FDA Proposal Will Require Additional Testing Requirements for AEDs

The FDA issued a proposed order on March 22nd that, if finalized, could potentially toughen the approval process for manufacturers of automated external defibrillators (AEDs). Under the proposed order, manufacturers will now be required to submit a pre-market approval application (PMA) or notice of completion of a product development protocol (PDP).  AEDs are used to prevent cardiac arrest in patients by delivering an electrical shock to re-establish normal cardiac rhythms. According to an article by The New York Times reporting on the proposed order:

There have been 45,000 reports of the devices failing or malfunctioning since 2005. . . .  The vast majority of them were due to manufacturing problems, . . . but some were because of improper maintenance, like battery failure. Manufacturers have recalled the devices 88 times in that period.

The article notes that while the new regulations would typically require manufacturers to conduct expensive and time-consuming clinical trials, many of the nine U.S. manufacturers of AEDs have already collected the necessary data, according to Dr. William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health.  For these manufacturers, Dr. Maisel stated that the cost of complying with the new regulations would rise from about $5,000 to about $220,000.

TranS1 Inc. To Acquire Baxano, Inc.

TranS1 Inc. announced today that it will acquire Baxano, Inc., a privately-held company based in California that develops tools to treat lumbar spinal stenosis.  According to the press release, Baxano manufactures the iO-Flex® System, a set of flexible instruments that allows surgeons to target lumbar spinal stenosis.

The press release states that TranS1 develops products to treat degenerative conditions of the spine affecting the lumbar region, including the AxiaLIF® family of products for single and two level lumbar fusion, the VEO® lateral access and interbody fusion system, and the Vectre™ posterior fixation system for lumbar fixation supplemental to AxiaLIF® fusion.

According to Ken Reali, President and CEO of TranS1:

Minimally invasive treatments are the fastest growing segment of the spine market. The combination of our AxiaLIF® and VEO® lumbar fusion products with Baxano’s iO-Flex® and iO-Tome™ systems for lumbar direct decompression and facetectomy, respectively, will allow us to better meet the needs of our spine surgeon customers.