Posts Tagged ‘Breakthrough Devices’

The Current Impact and Future of Technology within Cardiovascular Surgery

Reporter: Arav Gandhi, Research Assistant 2, Domain Content: Cardiovascular Diseases, Series A


Medical professionals have been able to explore new methods and strategies to tackle complex medical conditions, especially with the limitations of other pre-existing conditions. For instance, through recent cardiology advancements, if the patient requires a heart transplant due to heart failure disease and is unable to undergo a human donor heart transplant as a result of pre-existing disease conditions or existing internal bleeding complications, there is a greater alternative to leaving it untreated. Medical professionals developed alternatives to humman donor transplants. One such a solution is transplanting a genetically modified pig heart, a new advanced experimental procedure that has been used over recent cases. Researchers continue to develop solutions that not only presents an alternative to current methods but also continue to maximize the potential of medical devices technology and of our understanding of medicine.

Recently, cardiologists at Henry Ford Health Hospital found themselves as the first physicians in the United States to employ an investigational device to treat a patient with severe tricuspid regurgitation. Having never been experimented upon prior to the situation, the K-Clip Transvascular Tricuspid Repair System utilizes a corkscrew anchor, which then clips the ring-shaped region of the valve. Similar to most dire situations where new technology is used, the patient, an 85-year-old male, continued to experience worsening symptoms for an entire year. His tricuspid valve, key in ensuring blood flow to the right ventricle and then to the pulmonary valve, was enlarged from his condition, resulting in the mass of his heart tripling in size. Cardiologists were then prompted to either utilize the new procedure or go untreated. With optimism, the cardiologists selected the procedure and applied a unique approach of an incision through the neck to reduce further risks of opening the chest and placed the device using real-time 3D imaging and 4D modeling. The medical professionals followed a minimally invasive procedure through the neck in contrast to traditional open-heart surgery and effectively employed recent advancements in imaging and modeling to ensure precision when planting the device, a new artificial tricuspid valve. The patient was later reported to have experience improve in the valve condition and a significant decrease in leakage, along with an improvement in his overall quality of life. 

As a result, researchers should continue to focus not only on understanding undiscovered diseases and complications but also on developing alternative solutions to resolve cases in which the best practice approach can not be applied.

With the advancements in technology, the true extent of its application can not be discovered without experimentation and the application of imaging and other devices to resolve certain conditions. Beyond the technology itself, the introduction of new methods allows for less costly treatment plans, aiding especially those who come from a low-income background and currently struggle to afford basic healthcare. In the united States they are covered by MedicAid at all ages and by Medicare at age 65 and beyond. This is not the case in many countries in the World excluding Europe. The overall development of the field of medicine through advancement of medical technologies can indirectly allow for a improvement to the overall Global health care delivery and ascertain an increased life expectancies. This is primarily true, chiefly, in developing countries where established surgeries to resolve complex medical conditions still have the ability to achieve life-changing quality of life and longevity.

To learn more about the topic, check out the article below.


Walter, Michael. “Cardiologists Use New Annular Clipping Device for First Time in Us to Treat Severe Tricuspid Regurgitation.” Cardiovascular Business, Innovate Healthcare, 15 Sept. 2023, cardiovascularbusiness.com/topics/clinical/interventional-cardiology/cardiologists-severe-tricuspid-regurgitation-valve-k-clip?utm_source=newsletter

Other related articles on tricuspid valve procedures published in this Open Access Online Journal, include the following:

Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment


On Amazon.com since 12/24/2018

Chapter 13: Valve Replacement, Valve Implantation and Valve Repair


The Voice of Series A Content Consultant: Justin D. Pearlman, MD, PhD, FACC

As catheter techniques evolved to compete with bypass surgery they progressed from balloon cracking of obstructive lesions (POBA=plain old balloon angioplasty) to placement of stents (wire fences). Surgeons sometimes use in-stent valves, and now devices analogous to in-stent valves can be placed by catheter for valve replacement in patients with too much co-morbidity to go through heart surgery. Aortic valve replacement by stent (TAVR) has had sufficient success to be considered for all patients who have sufficient impairment to merit intervention. The diameter is large, so a vascular surgeon participates in the arterial access and repair of the access site.

13.5   Tricuspid Valve

13.5.1 First-in-Man Mitral Valve Repairs Device used for Tricuspid Valve Repair: Cardioband used by University Hospital Zurich Heart Team

Reporter: Aviva Lev-Ari, PhD, RN



13.5.2 Advances and Future Directions for Transcatheter Valves – Mitral and Tricuspid valve repair technologies now in development

Reporter: Aviva Lev-Ari, PhD, RN



Volume Six: Interventional Cardiology for Disease Diagnosis and Cardiac Surgery for Condition Treatment

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21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law

Reporter: Aviva Lev-Ari, PhD, RN



  • The 21st Century Cures Act seeks to expedite development of, and provide priority review for, “breakthrough” devices
  • The act requires FDA to provide training on the meaning and implementation of the least burdensome review standard, and requires an audit of the results
  • The act expressly excludes certain categories of medical software from FDA regulation

Major provisions of the act related to medical device regulation found in Subtitle F are listed, below.


President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries.

This alert summarizes the major provisions of the act related to medical device regulation found in Subtitle F.

Read more: http://www.btlaw.com/Food-Drug-and-Device-Law-Alert—Major-FDA-Reform-Bill-Becomes-Law-Medical-Device-Overview-12-13-2016/


Section 3051 – Breakthrough Devices

Section 3052 – Humanitarian Device Exemption (HDE)

Section 3053 – Recognition of Standards

Section 3054 – Certain Class 1 and Class II Devices

Section 3055 – Classification Panels

Section 3056 – Institutional Review Board Flexibility

Section 3057 – CLIA Waiver Improvements

Section 3058 – Least Burdensome Device Review

Section 3059 – Cleaning Instructions and Validation Data Requirement

Section 3060 – Clarifying Medical Software Regulation


A copy of the act can be found here.



For more information, please contact the Barnes & Thornburg LLP attorney with whom you work or one of the following attorneys in the firm’s Food, Drug & Device Group: Lynn Tyler at (317) 231-7392 or lynn.tyler@btlaw.com; Beth Davis at (404) 264-4025 or beth.davis@btlaw.com; or Alicia Raines Barr at (317) 231-7398 or alicia.rainesbarr@btlaw.com.

Visit us online at www.btlaw.com/food-drug-and-device-law-practices.





Other related articles published in this Open Access Online Scientific Journal include the following:

Medical Devices




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