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Boston Scientific Launches SpaceOAR Vue Hydrogel: Designed to Create a Temporary Space Between the Prostate & the Rectum

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November 16, 2020

SpaceOAR Vue Hydrogel, is a radiopaque version of SpaceOAR Hydrogel that provides the added benefit of enabling the use of computerized tomography scans instead of requiring magnetic resonance imaging.

Like its predecessor, SpaceOAR Vue Hydrogel is designed to create a temporary space between the prostate and the rectum, thus minimizing the potential side effects of radiation therapy for prostate cancer patients.

Prostate cancer is the most common non-skin cancer in American men. More than 183,000 new cases are diagnosed each year, and more than 60,000 of these patients opt to treat the condition with radiation.12 However, due to the close proximity of the rectum to the prostate, prostate radiation therapy can cause unintended damage to the rectum, which can lead to fecal incontinence issues or other long-lasting side effects. To reduce potential harm,perirectal spacers are recommended as a pre-treatment option within the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®).*

“SpaceOAR Hydrogel is already an important innovation in prostate cancer treatment to protect men from the unwanted side effects of radiation therapy,” said Marcio Fagundes, M.D., medical director of Radiation Oncology, Miami Cancer Institute, part of Baptist Health South Florida. “Now with SpaceOAR Vue Hydrogel, physicians have the added benefit of CT visibility of the hydrogel during radiation treatment planning and daily cone-beam computed tomography imaging. This added visibility expands its use in patients contraindicated for an MRI and, from my experience, will have the potential to improve the overall efficiency of treatment planning.”

The SpaceOAR Vue Hydrogel perirectal spacer is designed to offer similar clinical benefits as SpaceOAR Hydrogel, which was the first FDA-cleared hydrogel perirectal spacer and has been used in over 100,000 patients worldwide.3 In a randomized clinical study of the first-generation SpaceOAR Hydrogel, at median three years, more men in the control group than in the spacer group had experienced declines in bowel (41% vs 14%) and urinary (30% vs 17%) quality of life.4 Additionally, more men who were potent at baseline and treated with SpaceOAR were able to achieve erections sufficient for intercourse (66.7%, vs. 37.5% in the control group).5

“SpaceOAR Vue Hydrogel demonstrates our commitment to continually respond to the needs of healthcare professionals to help them provide patients with the best care possible,” said Meghan Scanlon, senior vice president and president, Urology and Pelvic Health, Boston Scientific. “With SpaceOAR Vue Hydrogel, physicians may be able to improve the department’s procedural workflow by creating treatment plans using only a CT scan, thereby reducing the need for patients to obtain a post-procedural MRI scan.”


1 Leading Cancer Cases and Deaths, Male, 2015. Centers for Disease Control and Prevention. Gis.cdc.gov/Cancer/USCS/DataViz.html. Accessed February 25, 2019.

2 Treatment for Prostate Cancer: External-Beam Radiation Therapy. Prostate Cancer Foundation. https://www.pcf.org/c/treatment-for-prostate-cancer-external-beam-radiation- therapy/. Accessed February 13, 2019.

3 Number of patients is based on units shipped and a Boston Scientific proprietary algorithm

4 Hamstra DA, Mariados N, Sylvester J, et al. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys. 2017;97(5):976-985.

5 Hamstra DA, Mariados N, Sylvester J, et al. Sexual quality of life following prostate intensity-modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018;8(1):e7-e15.

Source: https://infomeddnews.com/spaceoar-vue-hydrogel-launched-boston-scientific/

Medical Devices

Elcam Medical Joins Serenno Medical as Strategic Investor and Manufacturer of its Automatic Monitoring of Kidney Function Device

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January 20, 2021

Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, announced today that Elcam Medical, a leading producer of medical devices, has invested  $1.5 million in the Company and will also manufacture SentinelTM, Serenno’s urine output and intra-abdominal pressure digital monitoring device for the detection of acute kidney injury (AKI). Elcam Medical join existing investors Alon Medtech and serial medical device inventor, entrepreneur and investor, Dr. Shimon Eckhouse.

The partnership announced today combines Serenno’s unique solution with Elcam’s superior manufacturing experience to deliver high quality products at a competitive price, that will enable the use of Sentinel in a variety of hospital environments.

Continuous kidney function assessment allows the early detection of AKI, a common condition in hospitalized patients that significantly increases risk of mortality during and after hospitalization. Accurate measurement of urine output (UO) is clinically accepted as the best method for monitoring changes in kidney function. However, UO is currently monitored intermittently and manually by ICU staff, therefore acute changes in urine flow are difficult to detect. Thus, kidney injury is often detected relatively late, sometimes after it is impossible to prevent further progression.

Beyond the high death toll associated with kidney failure routinely in the ICU, the recent spread of COVID19 had greatly increased prevalence of, and death from AKI, while vastly increasing the demand and exposure risk on medical professionals and ICUs worldwide.

Sentinel offers a simple and cost-effective solution for the precise, continuous measurement of urine volume and flow rate in real time. The system promotes early detection of kidney injury, while there is still time to intervene and prevent further damage. It aims to automatically and accurately detect small changes in kidney function, allowing remote detection by the medical staff, thus reducing both patient and caregiver risk.

“The investment by Elcam Medical is a strong endorsement, and will allow us to swiftly move toward commercialization of our device,” said Tomer Lark, Serenno’s co-founder and CEO. “Elcam’s world class production capabilities and experience, will enable mass production and increased market access of Sentinel. Our plan is to begin deployment of the devices in several US hospitals towards the end of 2021, in the hope to eventually reduce kidney failure risk for every patient at ICUs.”

Dr. Shimon Eckhouse, Serenno’s Chairman, added, “We are pleased with Elcam’s investment, which marks the first commitment in Serenno’s larger planned current financial round. This partnership with Elcam is an excellent indication of the high degree of innovation and the significance of Serenno’s solution for the advancement of monitoring technologies. We are confident that Elcam’s leadership position in the global point-of-care market will play a critical role in bringing Serenno’s exciting technology to ICUs and patients around the world.”

“Our investment in Serenno and the establishment of a production line for its device is aligned with Elcam’s strategy to cooperate with promising Israeli startups to deliver products with added value for the patient,” said Igal Kohn, Elcam Medical’s CEO. “Elcam Medical has joined Serenno as a board member and we look forward to taking part in the Company’s continued successes.”

Source: https://infomeddnews.com/elcam-medical-joins-serenno-medical-as-strategic-investor/

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India begins scaling up syringe supplies for Covid19 vaccination

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Best Coronary Stents from the Top Brands

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The total coronary stent market comprises bare-metal stents, drug-eluting stents, covered stents, and bifurcated stents. Stents can be defined as small mesh tubes inserted into an artery to prevent it from collapsing and keep it open after an angioplasty surgery (percutaneous coronary intervention, or PCI). Following multiple clinical studies that presented evidence of over-stenting in the U.S market, the value of the overall market has decreased through 2019 and is expected to trend downwards over the coming years, outside of COVID-19-related fluctuations. We have identified the different types of stents and analyzed their benefits and draw-backs:

Top Companies for Coronary Stents by Market Share

1. Boston Scientific – The leading competitor in the coronary stent market was Boston Scientific. Most of the company’s success can be attributed to its strong position in the drug-eluting stents (DES) market, where it held the leading share.

The company currently offers the SYNERGY™ and REBEL™ BMS product line. SYNERGY™ is the first and only FDA-approved DES with abluminal bioabsorbable polymer coating available in the U.S. coronary stent market. REBEL™ is made of a platinum chromium alloy, which is designed to reduce device usage, procedure times, and radiation exposure.

2. Medtronic – Medtronic is the second-leading competitor and maintained a notable position in both the bare-metal stents (BMS) and drug-eluting stents (DES) markets. Through strategic acquisitions and aggressive bundling, Medtronic has increased its share across the interventional cardiology market in recent years.

The company currently offers the Resolute Onyx™ and Resolute Integrity™ DES product lines, as well as the Integrity™ BMS product line. Unlike Boston Scientific and Abbott’s DES devices, which use the everolimus drug, Medtronic’s DES devices use zotarolimus. 

3. Abbott  – Abbott is the third-leading competitor in the coronary stent market. Competition between Abbott and Medtronic has increased within the DES market, resulting in Abbott losing share in recent years.

The company currently offers the XIENCE™ and Multi-Link Vision™ product lines. Multi-Link Vision™ has been the leading BMS in the U.S. since its introduction. It is constructed of a cobalt-chromium alloy that is more radiopaque than stainless steel stents. This alloy is also stronger than stainless steel, which allows stent construction to be much thinner while still retaining its strength.

Coronary Stent Market Trends – By Type

1. Drug-eluting stents (DES) – All stents have a risk that scar tissue will form and narrow the artery again. This scar tissue can block blood flow. However, drug-eluting stents are coated with drugs that prevent scar tissue from growing into the artery. DES are used for an overwhelming majority of stenting procedures, due to the continued publication of clinical studies supporting their safety and efficacy as the gold standard for stenting procedures. With this clinical backing, the DES market sits at over $1 billion.

However, due to increased bundling and competitive pricing, significant ASP depreciation resulted in negative market value growth in 2019. Negative to flat growth is expected to continue for most of the next few years.  

2. Bare-metal stents (BMS) – “Bare-metal stents are mesh-like tubes of thin wire without a coating or covering. Ideally, bare-metal stents will be covered by a new layer of endothelial cells, sealing it into the vessel wall, within a few weeks after implant.” – DAIC.

Bare-metal stents were once the gold-standard choice for stenting procedures but have lost substantial share to drug-eluting stents. It is expected that the segment will continue to contract in market value in the upcoming years with decline rates in the double-digits. 

3. Covered stents – Covered stents are composed of fabric or graft material, such as polytetrafluoroethylene (PTFE), covering a metal stent. These devices are seldom used and are indicated for the treatment of free perforations of native coronary arteries or saphenous vein grafts, which would have been treated with a coronary artery bypass graft (CABG) procedure in the past.

The incidence rate of coronary perforation has historically been low. It is estimated to occur in less than 1% of percutaneous coronary intervention (PCI) procedures performed in the United States.

4. Bifurcated stents – Bifurcated stents represent a small fraction of the total market value. Tryton Medical’s TRYTON® Side Branch was the first dedicated bifurcated stent to be approved in the U.S. market, in March 2017. 

The segment was once expected to experience very rapid growth, due to the strategic alliance between Tryton and Cardinal Health. However, after the first year on the market, unit sales declined sharply, due to a lack of clinical studies for and efficacy of the stents.

Coronary Stent Market Analysis and Forecast

Overall, the U.S. Coronary Stent market size was valued at over $1 billion in 2020. This is not expected to increase by much over the next few years, as the market observed a loss of 22% resulting from the impacts of COVID19. This is expected to bounce back with growth over the next 2 years but then drop off again as stents become less used in surgeries.

Register to receive a free US Market Report Suite for Interventional Cardiology Devices  2020 – 2026 synopsis

Source: https://idataresearch.com/best-coronary-stents-from-the-top-brands/

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Occlutech Announces Atrial Flow Regulator Has Received U.S. FDA Breakthrough Device Designation for Heart Failure

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January 19, 2021

Occlutech, a Swiss-based privately-held company reported that the FDA has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction.

Heart failure (HF) is a serious condition characterized by the heart’s inability to pump an adequate blood supply to the body. Worldwide, HF affects over 30 million people, and the lifetime risk of HF increases with age, with over 50% of hospitalizations of persons aged 65 or older attributable to HF. Heart Failure Symptoms include fatigue, palpitations, and exertional dyspnea. HF may result from disorders of the pericardium, myocardium, endocardium, heart valves, great vessels, or specific metabolic abnormalities. These disorders affect the heart’s structure or function, which results in reduced cardiac output and/or elevated intracardiac pressures at rest or during exercise. When HF is left untreated, symptoms gradually worsen, resulting in increased morbidity, clinically driven hospitalizations, and higher mortality.

The AFR is for use in patients with Heart Failure with Preserved Ejection Fraction (HFpEF) or Reduced Ejection Fraction (HFrEF) and who, despite optimal medical therapy, experience worsening symptoms. The AFR maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. Reduced left atrial pressure has been shown to reduce heart failure symptoms and improve exercise tolerance.

Breakthrough Device Designations aim to accelerate the development, assessment, and approval of new treatments in severe diseases, including a prioritized review all the way through market approval.

“It is an important milestone for us to have received this second breakthrough designation for our AFR device.” says Sabine Bois, CEO Occlutech Group. “After receiving the first Breakthrough Device designation for pulmonary arterial hypertension (PAH) in December 2020, the heart failure (HF) indication addresses a substantial market with rapid growth and only limited options for the treatment for critically ill patients. We are looking forward to developing an important new therapy and working closely with the FDA on both indications.”

Occlutech is one of the leading companies in its field, with several major products including state-of-the-art PFO occluders, ASD occluders among others. Occlutech has sales of congenital and structural heart products in over 80 countries and maintains manufacturing and R&D facilities in Jena, Germany and Istanbul, Turkey. Occlutech has developed many novel products and technologies to improve treatment of patients in these and related areas.

The AFR is not approved in the United States.  Product availability is subject to local regulatory clearance. The AFR is under clinical investigation for use in patients with pulmonary arterial hypertension and use in these patients is limited by applicable national laws.

Source: https://infomeddnews.com/occlutech-atrial-flow-regulator/

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