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Edwards SAPIEN 3 Cardiac Valve FDA Approved for Mitral and Aortic Valve-in-Valve Procedures

Edwards SAPIEN 3 Cardiac Valve FDA Approved for Mitral and Aortic Valve-in-Valve Procedures

Edwards Lifesciences received FDA approval for its SAPIEN 3 transcatheter prosthetic heart valve to be used for valve-in-valve procedures. Indicated for placement within both the aortic and mitral valves in patients at risk of undergoing open heart surgery to remove an existing valve, the SAPIEN 3 can reside within a previously implanted bioprosthetic valve that has begun to fail. The device was previously approved in the U.S. for treatment of severe, symptomatic aortic stenosis in patients at high risk for open-heart surgery, as well as for patients that are at intermediate risk for open-heart surgery that would benefit from the SAPIEN 3. “This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery,” said John Carroll, M.D., professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver and member of the TVT Registry Steering Committee. “I am pleased to see that the FDA recognizes the value of the high-quality evidence generated by the STS-ACC TVT Registry and its ability to play an important role in assessing ‘real-world’ clinical results in specialty indications, such as valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic mitral valve.” Flashbacks: Edwards SAPIEN 3 Aortic Heart Valve Approved in U.S…; Edwards Sapien 3 Prosthetic Aortic Heart Valve Approved in Europe… Product page: Edwards SAPIEN 3 Transcatheter Heart Valve… Via:...
SandShark Anchor for Fixating Stimwave’s Neurostimulators Cleared in Europe

SandShark Anchor for Fixating Stimwave’s Neurostimulators Cleared in Europe

Most implantable neurostimulation systems consist of a pulse generator, that looks like a pacemaker, and electrode leads through which electric current is delivered. Stimwave Technologies out of Ft Lauderdale, Florida, has developed neurostimulation systems in which only the electrode component is implanted, while power is delivered wirelessly via a separate device placed against the skin near the implant. Now the company’s SandShark percutaneous injectable anchor system has been approved in Europe that helps to affix Stimwave’s implantable wireless neurostimulators within the target tissue. Implantation is a minimally invasive procedure that can be performed in an outpatient setting. It involves first injecting the stimulator, which is only a few millimeters long, and then sliding the SandShark over the implant and pushing it toward ligaments or other hard connective tissues. The anchor can be seen under X-ray fluoroscopy, and once in place, a mechanism is activated to open up the anchor’s wings so it’s locked in place. The orientation of the implant is preserved during the process, helping to make sure it’s aligned properly with the nearby target nerves. Flashback: Stimwave Freedom, World’s Smallest Neurostimulator, FDA Cleared for Back, Leg Pain… Via:...
Video Demonstration and Update of Spectranetics’ Bridge Occlusion Balloon

Video Demonstration and Update of Spectranetics’ Bridge Occlusion Balloon

More than 7 million patients worldwide live with pacemakers or implantable cardioverter defibrillators (ICDs). These devices are connected to the heart through leads. In some cases, such as lead infection, failure, or recall, it becomes necessary to extract the leads and replace them with new ones. At this time, 15,000 to 20,000 lead extractions are performed annually in the United States. Although this procedure is relatively safe, superior vena cava (SVC) tears remain one of the most dangerous complications and dissuade some physicians and patients from pursuing this treatment. SVC tears occur in only about 0.5 percent of cases, but when they do occur, the mortality rate nears 50 percent. Spectranetics is a Colorado-based company that is currently a pioneer in cardiac lead management. Spectranetics aspires to mitigate the high mortality rate associated with SVC tears during lead extraction with its new product, Bridge Occlusion Balloon. Spectranetics launched Bridge Occlusion Balloon last year. The device requires a stiff guide wire that is inserted through the right femoral vein and threaded up to the right internal jugular vein prior to initiating the lead extraction procedure. If a SVC tear occurs, the balloon can be deployed in less than two minutes to temporarily halt bleeding from the tear by obstructing blood flow through the superior vena cava. Of course, the balloon does not substitute surgical repair, but it acts to stabilize the patient long enough for the cardiac surgeon to open the patient’s chest and repair the tear. During the Heart Rhythm Society 2017 Scientific Sessions in Chicago, Dr. Roger Carrillo of the University of Miami presented a new study on how...
Interview With Director of Biomaterials Research Innovation Center, Prof. Ali Kadhemhosseini

Interview With Director of Biomaterials Research Innovation Center, Prof. Ali Kadhemhosseini

The fields of tissue engineering, regenerative medicine, and drug delivery are burgeoning due to the development of new technological advancements in engineering, material science, and chemistry. At the confluence of such diverse fields lies the Biomaterials Innovation Research Center. Located in the hub of Boston, in the Brigham and Women’s Hospital, the center is directed by Dr. Ali Kadhemhosseini. His laboratory is at the forefront of developing micro- and nano scale biomaterials to direct cellular behavior toward a final goal of advanced tissue engineering. He is particularly well known for his broad expertise in multiple technologies. His laboratory has pushed the boundaries of micro fabrication techniques, such 3D printing, photo lithography, and microfluidics, to build complex tissues that more accurately mimic organs in the body. One of the major things his laboratory aims to do is to use innovations in microengineering technology to create artificial tissues that closely mimic the architecture of native tissues. He has won several awards for his contributions to the field of biomaterials, the most recent being an award from the Society of Biomaterials. We recently had an opportunity to interview Dr. Kadhemhosseini to find out more about their work. Rukmani Sridharan, Medgadget: Congrats on your recent 2017 Clemson Award for Contributions to the Literature from the Society for Biomaterials. Where do you derive your inspiration from and who are your mentors you look up to in your field? Dr. Kadhemhosseini: I get inspiration from seeing other great people do great work.  My mentors Bob Langer and Nicholas Peppas are two great examples of this.   Medgadget:  Your recent paper outlining the liver-on-a-chip technology has...
The Digital Health Update by Paul Sonnier ⋅ Jun 1, 2017 ⋅ #277

The Digital Health Update by Paul Sonnier ⋅ Jun 1, 2017 ⋅ #277

I made this announcement to 56,235 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ Jun 1, 2017 ⋅ #277 Dear Group, As previously mentioned, I’m seeking a direct role with a company or organization that would, ideally, complement and leverage all that I’ve built and am doing, including my keynote speaking, weekly newsletter, Digital Health LinkedIn group, and contributing editor role at Innovation and Tech Today. My professional bio is viewable here. Please contact me if you see a potential fit or would like to advertise in my announcements, newsletter, and website. Please do not contact me with partnering or commission-type offers. I’ve published two issues of The Digital Health Newsletter since last week’s group announcement. I’ve copied and pasted the text from each newsletter below for better web-search (SEO) and archival purposes. The Digital Health Newsletter by Paul Sonnier for May 27, 2017 Venture capitalists are increasingly betting on sleep-focused startups , which is a great thing considering the latest analysis on poor sleep and its association with an increased risk of death. As Joanna Glasner reports in TechCrunch, sleep-focused startups have raised more than $700 million in the past couple...
Videssa Breast Blood Diagnostic Test for Breast Cancer

Videssa Breast Blood Diagnostic Test for Breast Cancer

Provista Diagnostics, a company based in New York City, has developed the Videssa Breast blood-based proteomic test to detect breast cancer. At present, after an abnormal mammogram doctors are faced with a difficult decision: whether to carry out an invasive biopsy or not. “When a mammogram yields an abnormal result, the challenge for every clinician is to decide which patients need follow-up, further imaging or biopsy,” said Josie R. Alpers, MD, a radiologist at Avera McKennan Hospital & University Health Center. The Videssa Breast diagnostic test aims to provide doctors with a third option, a simple blood test to test for breast tumor biomarkers in the blood. The idea is that the test can help to rule in or out further biopsies or imaging. “With about 1.6 million breast biopsies performed each year, the implications of a blood test that can help clinicians confidently rule out breast cancer and avoid a potentially unnecessary biopsy are tremendous,” said Judith K. Wolf, MD, Provista Diagnostics Chief Medical Officer. The diagnostic test works by using ELISA technology to measuring levels of proteins in the serum that have been identified as associated with breast cancer. This includes a panel of 11 serum protein biomarkers and 33 tumor-associated autoantibodies, produced by the body in response to breast tumors. The test uses antibodies to bind the biomarkers and autoantibodies in the blood sample, to allow their levels to be measured. The diagnostic test was recently trialed in a group of women under 50 years old, who are more difficult to assess for breast cancer using imaging techniques. The women had abnormal or difficult-to-interpret breast imaging results. The...
New Metamaterial Helps Improve High Field MRI Scans

New Metamaterial Helps Improve High Field MRI Scans

Scientists from Leiden University in The Netherlands and ITMO University in Moscow, Russia have developed a new material that improves the image quality of high-field MRI scanners. The material can be used along with existing MRI coil arrays, as it’s flexible and is not very thick, and so can be integrated near the coils. The material consists of a two-dimensional “metamaterial” of resonant copper strips, and a dielectric substrate stuck to the strip array. Using a 7 Tesla scanner, which is considerably more powerful than what is widely used in clinical practice today (3T max), they were able to obtain neurological images of higher quality than when not using the new material. Moreover, in addition to being able to acquire better scans, the material may help speed up scans, a major bottleneck in a lot of countries. “We placed such a metasurface under the patient’s head, which increased local sensitivity by 50%. This allowed us to obtain detailed scans of the occipital cortex in half the usual time. Such devices could potentially reduce the duration of MRI studies and improve its comfort for subjects”, in a published statement said Rita Schmidt, the leading author of the paper and researcher at the Department of Radiology of Leiden University Medical Center. Study in journal Scientific Reports: Flexible and compact hybrid metasurfaces for enhanced ultra high field in vivo magnetic resonance...
PREVENA DUO Negative Pressure Wound Therapy Treats Two Incisions at Same Time

PREVENA DUO Negative Pressure Wound Therapy Treats Two Incisions at Same Time

Acelity, based in San Antonio, Texas, is releasing the PREVENA DUO Incision Management System, a disposable negative pressure wound therapy (NPWT) system that can be used to manage two surgical incisions at the same time. The company expects the PREVENA DUO to be used post vascular harvesting, breast reconstruction, and ortho trauma procedures that often result in more than one incision. Negative pressure wound therapy has been shown effective to treat a variety of wound types and many practices have been adopting it as a regular part of post-op rehab to prevent infections and speed up healing of wounds. PREVENA, the single site treatment device, has had extensive use already. Here’s some info from Acelity regarding the studies of the PREVENA: Clinical studies have demonstrated the efficacy of PREVENA™ Incision Management System in significantly reducing the incidence rate of infections. According to one study led by Tim Matatov, M.D., Louisiana State University Health Sciences Center, evaluating the PREVENA™ Incision Management System in reducing the risk of groin wound infection after vascular surgery, PREVENA™ Therapy was found to reduce the incidence of groin wound infection compared to traditional skin adhesive or absorbent dressings (6 percent incidence of infection with PREVENA™ Therapy compared to 30 percent with control group). As groin incisions are prone to complications and the incidence of groin SSIs after vascular surgery can be as high as 44 percent, prevention is a key component of improving patient care. The results also indicated significant cost savings with the PREVENA™ Incision Management System. In fact, the study authors concluded that the cost of the PREVENA™ System was quickly exceeded by the traditional...
The Digital Health Update by Paul Sonnier ⋅ May 25, 2017 ⋅ #276

The Digital Health Update by Paul Sonnier ⋅ May 25, 2017 ⋅ #276

I made this announcement to 56,125 members of the Digital Health group on LinkedIn. If you’re on LinkedIn, please do join the group, which allows you to opt in to receiving these announcements in addition to connecting with thousands of other global stakeholders in digital health. Note that I will continue to update this announcement up until sending out the final version via LinkedIn. I’m also now using Constant Contact to send an html and image-rich version of my announcements. You can subscribe to that version here. The Digital Health Update by Paul Sonnier ⋅ May 25, 2017 ⋅ #276 Dear Group, Please note that I’m seeking a direct role with a company or organization, e.g. as Chief Digital Officer. My professional bio is viewable here. Please contact me if you see a potential fit or would like to advertise in my announcements, newsletter, and website. Please do not contact me with partnering, equity-only, or commission-type offers. I’ve published three issues of The Digital Health Newsletter since last week’s group announcement. I’ve copied and pasted the text from each newsletter below for better web-search (SEO) and archival purposes. The Digital Health Newsletter by Paul Sonnier for May 20, 2017 Will consumers be able stomach gene editing better than GMOs? That’s the pointed question Jade Scipioni of FOX Business recently asked Dr. Robert Fraley, aka ‘the godfather of GMOs’, and chief technology officer for Monsanto. As Dr. Fraley states, “Gene editing is probably one of the most exciting new techniques in biology. It’s going to have applications for human healthcare, for agriculture, both in producing better crops and better livestock. With gene editing,...
Cordis Unveil New Interventional Cardiology Products

Cordis Unveil New Interventional Cardiology Products

The RAILWAY Sheathless Access System Cordis, the interventional vascular arm of Cardinal Health, has announced three new additions to its cardiology portfolio for use in Europe, the Middle East, and Africa. The new products were on show at EUROPCR 2017 in Paris this week and include the RAILWAY Sheathless Access System and two new percutaneous transluminal coronary angioplasty (PCTA) balloon catheters: the Ikazuchi Zero and Raiden3 under the Kaneka brand name. The RAILWAY Sheathless Access System is indicated for radial artery use and allows direct access to the artery for introducing intravascular devices. The system completely eliminates the need for an introducer sheath and is optimized for use with ADROIT and VISTA BRITE TIP guide catheters, resulting in a two-French reduction in system size. The system is also compatible with other Cordis 5F, 6F, and 7F guide catheters across all shapes, including dedicated radial shapes. Ikazuchi Zero PTCA balloon catheter In October 2016, Cardinal Health entered into a distribution agreement with manufacturer Kaneka, giving Cordis access to the Japanese balloon catheters. The new balloon catheter offerings have received CE mark approval, and are suitable for treating smaller and narrower legions in both everyday and complex PTCA cases. The Ikazuchi Zero catheter represents the lowest-profile 1.0mm diameter pre-dilation balloon available and features a new coating to improve trackability. The Raiden3 system offers improved inflation accuracy, even after repeated inflation/deflation cycles, and also boasts a 22atm rated burst pressure, one of the highest ratings on the market. Via: Cardinal...