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Small study yields ‘really good news’ for COVID-19 vaccine odds

Alba Grifoni, a postdoctoral researcher in the Sette lab and study first co-author, tests the T cell response in blood samples collected from individuals who have recovered from COVID-19. (Image from the La Jolla Institute of Immunology)

Scientists at the La Jolla Institute for Immunology have documented a robust antiviral immune response to SARS-CoV-2 in a group of 20 adults who had recovered from COVID-19.

Their work, published in today’s online edition of Cell, show that the body’s immune system is able to recognize SARS-CoV-2 in many ways, dispelling fears that the virus may elude ongoing efforts to create an effective vaccine.

The collaboration between the labs of Alessandro Sette and Shane Crotty, both professors at the institute’s Center for Infectious Disease and Vaccine Research, offers some good news for vaccine developers and is providing the first cellular immunology data to help guide soc…

Medtronic touts positive results for Melody TPV, Harmony TPV

Medtronic (NYSE:MDT) today announced the results of two successful clinical trials for its Melody transcatheter pulmonary valve (TPV) therapy.

The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV pivotal trial met safety and efficacy endpoints for hemodynamic function at six months, according to a news release.

Melody TPV demonstrated consistent hemodynamics through 10 years with strong valve efficacy with 97% none/trace/mild pulmonary regurgitation. Annualized incidence of TPV-related endocarditis was 2% per patient-year, while freedom from major stent fracture came in at 84% at 10 years and freedom from reintervention was 61%.

That study included 150 implanted patients between age 7 and age 53, with a median age of 19 and …

How do medtech investors, CEOs manage portfolio companies going forward?

DeviceTalks Weekly

In Episode 10 of DeviceTalks Weekly, we talk with two successful starters of medtech companies about how they’re building and maintaining their medtech portfolios during this pandemic landscape.

Our guests this week are Dr. Justin Klein, managing partner of Vensana Capital, and Duke Rohlen, chair of Ajax Health. Together, Klein and Rohlen have created, backed and sold medtech companies that have generated billions.

Klein, formerly of New Enterprise Associates, now co-manages his own venture firm, Vensana Capital. He previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), EPIX Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical and Vytro…

Hologic granted second molecular COVID-19 test EUA

Hologic (NSDQ:HOLX) announced today that it received FDA emergency use authorization (EUA) for its Aptima SARS-CoV-2 assay for detecting COVID-19.

Marlborough, Mass.-based Hologic’s Aptima test runs on its fully automated Panther system that provides initial results in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours.

Hologic said in a news release that it began distributing the new test and expects to produce an average of one million tests per week by combining its manufacturing capacity with what it touts as the world’s largest installed base of high-throughput molecular instruments.

Aspects of the Aptima assay project were conducted under a $13 million contract from the U.S. Dept. of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA).

Hologic intends to register the Aptima SARS-CoV-2 assay for CE Mark approval in Europe later this month, according …

Dexcom completes sale of $1.05B in notes

Dexcom (NSDQ:DXCM) announced that it completed the sale of $1.05 billion aggregate principal amount of its convertible senior notes.

The San Diego-based continuous glucose monitoring system developer announced earlier this week that it was offering $850 million in notes with plans to offer note purchasers a 13-day option to buy up to an additional $150 million aggregate principal amount of notes.

A day later, the company increased the aggregate principal amount and granted a 13-day option to purchase up to an additional $157.5 million in notes, upsizing the total to the $1.05 billion it sold.

DexCom expects that the net proceeds will total approximately $1.03 billion, or $1.19 billion if the initial purchasers exercise their option to purchase the additional notes. The company used approximately $282.6 million of the proceeds to pay the cash consideration and issued more than 1.9million shares of its common stock to repurchase or exchange approximately $…

Balt wins IDE approval to start STEM trial

Balt announced that it received FDA investigation device exemption (IDE) for its trial for the treatment of chronic sub-dural hematoma.

The Squid trial for the embolization of the middle meningeal artery (STEM) is a prospective, randomized controlled trial for Balt’s Squid liquid embolic device as a minimally invasive treatment option for the neurological disease.

Irvine, Calif.-based Balt will investigate the safety and effectiveness of middle meningeal artery (MMA) embolization with the Squid device for managing CSDH in both surgical and non-surgical patients.

Co-primary investigator Dr. Adam Arthur of the Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center said in a news release that the study will help to understand how to treat a major reversible cause of dementia and disability in the elderly.

“The approval of the IDE for the STEM trial represents a significant milestone for Balt as this wil…

Study: PPE shortages persist nationwide

(Image from GetUsPPE)

Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet.

The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers from Harvard Medical School, Massachusetts General Hospital, Alpert Medical School at Brown University, Google and Pymetrics.

Most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%), according to the study. High COVID-19 infection and death rates have been reported at nursing homes across the country.

Metropolitan areas comprised 5,416 (8…

Study: PPE shortages persist nationwide

(Image from GetUsPPE)

Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet.

The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers from Harvard Medical School, Massachusetts General Hospital, Alpert Medical School at Brown University, Google and Pymetrics.

Most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%), according to the study. High COVID-19 infection and death rates have been reported at nursing homes across the country.

Metropolitan areas comprised 5,416 (8…

RespiraWorks, ICS partner on inexpensive ventilator for developing countries

RespiraWorks. and Integrated Computer Solutions (ICS) announced a partnership to collaborate on the former’s open-source ventilator.

San Francisco-based Respiraworks touts the medical-grade device as capable of being assembled for less than $500. The company designed the system for long-term vs. crisis use and for developing countries with the intent to source and manufacture locally, according to a news release.

A volunteer group of mechanical, process, electrical and controls engineers formed RespiraWorks last month to combine their knowledge of life support and critical engineering applications amid the COVID-19 pandemic.

“While most teams are addressing the need for “bridge” type ventilators to keep someone alive for six to eight hours, we are not aware of any tackling the ventilators for longer-term needs in an open-source, supply chain-optimized manner, and that’s where this team provides value,” RespiraWorks founder Ethan Chaleff said in the…

FDA warns on accuracy of Abbott rapid COVID-19 test

Abbott’s ID Now test machine (Image from Abbott)

After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.

Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”

A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.

One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…

Boston Scientific prices $1.7b offering

Boston Scientific (NYSE:BSX) announced that it priced a public offering of senior notes under its shelf registration statement worth $1.7 billion.

Marlborough, Mass.-based Boston Scientific is offering $500 million in aggregate principal amount of 1.9% notes due in 2025, along with $1.2 billion in aggregate principal amount of 2.65% notes due in 2030.

The company expects the offering to close on May 18, subject to customary closing conditions, according to a news release.

Once it closes the offering, Boston Scientific said it plans to use the proceeds to refinance $450 million in borrowings under its revolving credit facility and a portion of its pre-payable bank debt, which includes $750 million under a $1 billion term loan credit facility maturing in 2021 and $500 million under a $1.25 billion term loan credit facility maturing in April 2021.

Barclays Capital, Citigroup, J.P. Morgan Securities and Wells Fargo Securities are acting as the joint b…

Allergan, Ideal Implant targets of FDA warning letters

The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements.

One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant (Dallas, Texas) for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.

Every manufacturer of FDA-approved silicone gel-filled breast implants must conduct post-approval studies to further evaluate the implants’ safety and effectiveness and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre…