How Material Testing can Assure Quality in Stent Manufacturing

QMED article from Sep.30, 2013 at:

http://www.qmed.com/mpmn/medtechpulse/how-materials-testing-can-assure-quality-stent-manufacturing

From the article:

Comprised of biocompatible metal or biodegradable polymers, stents bear a complex geometry, enabling them to act as effective scaffolds. As they must be able to push against the internal walls of the blood vessel or other conduit into which they are placed, their mechanical integrity is of the utmost importance. An insufficient level of flexibility can result in tissue damage while insufficient rigidity inhibits the device’s capacity to support natural flow.

Designed to address specific applications, stents are available in a wide range of sizes, diameters, mesh patterns, and strengths.An intraluminal coronary artery stent is a small, self-expanding, metal mesh tube placed inside a coronary artery following a balloon angioplasty procedure. This particular type of stent is designed to prevent the artery from re-closing. As it is placed within an artery, it is subjected to rather large forces that must be thoroughly characterized during the product development cycle and as part of quality management initiatives.

Zwick PrecisionLine Vario system
The Zwick PrecisionLine Vario system

Drug-eluting stents are among the most recent types of stents approved for use. Coated with time release pharmaceutical compounds, drug-eluting stents are also utilized in cardiovascular procedures to maintain blood flow. According to the New England Journal of Medicine, more than 500,000 patients in the United States are implanted with drug-eluting stents annually. A chief benefit is the reduced risk of repeat revascularization, a condition in which the patient requires additional cardiovascular procedures.

CES 2014 (Consumer Electronics Show) Highlights Some Impressive Inventions

The CES (Consumer Electronics Show) in Las Vegas, NV is famous for being “the” place to debut exciting new technology.  The 2014 CES appears to live up to the history of the show.

This article in DesignNews gives some highlights and further details:

Gadget Freaks Rejoice: CES Highlights Impressive Inventions
Take a look at some new gadgets from last week’s Consumer Electronics Show in Las Vegas — a self-balancing electric skateboard, a sensor family that will keeps you on track, and a protective iPhone battery case with 32GB built-in storage.

As a new owner of an iPhone 5s, Mophie’s Space Pack looks very interesting (more battery life and more storage are always important!!). The big question is how much added thickness and added weight.  The form factor in the photo below looks impressive and the Space Pack adds up to 32GB of storage and is claimed to add 100% to the standard battery capacity of the iPhone.  You do need a protective case anyway, right??

Space Pack

The space pack adds extra storage for your iPhone 5/5s.   (Source: Mophie)

The space pack adds extra storage for your iPhone 5/5s. (Source: Mophie)

 Mophie’s space pack not only serves as extra battery life, but it also increases the storage to your iPhone 5/5s. This protective battery case with built-in storage increases your iPhone battery by 100 percent and gives you up to 32GB of extra memory.

There is also a Space app that allows you to organize, share, and access the content on the space pack’s storage. Once items are stored, you can access all the files without any network data usage. Another perk is that a USB cable is included so you can charge and sync your iPhone and space pack at the same time.

You can pre-order the space pack for $149.95 for the 16GB or $179.95 for the 32GB versions, beginning in March 2014.

Is Zinc the Perfect Material for Use in Bioabsorbable Stents?

Much of the development around bioabsorbable stents and other bioabsorbable implants have focused on a polymer, PLLA (poly-L-lactic acid) as the base material.  Some new research indicates that a Zinc alloy may make a better bioabsorbable stent as compared to PLLA.  The Zinc would degrade through a corrosion mechanism.

For more information, see:

QMED Online, Jan.16, 2014:

  • http://www.qmed.com/mpmn/medtechpulse/stent-designers-think-zinc?cid=nl.qmed02

“…The most advanced absorbable stents available today are made from polylactic acid (PLLA). Based on nearly five years of clinical trial data, for example, Abbott Vascular’s bioresorbable Absorb scaffold compares favorably to the company’s metal-based XIENCE stent, the current industry standard for nonabsorbable drug-eluting stents….”

Also, see the link to research by Patrick Bowen, Jaroslaw Drelich, and others at Michigan Tech from April 30, 2013 with figures:

  • http://www.mtu.edu/news/stories/2013/april/story88993.html#idc-container

Patrick Bowen also indicates that a preprint of the paper accepted for publication in Journal of Advanced Materials, March 14, 2013, entitled: “Zinc Exhibits Ideal Physiological Corrosion Behavior for Bioabsorbable Stents”  is available at:

Some highlights of the discussion include:

Understatement time: Federal Reserve Chairman Ben Bernanke Likens 2008 Financial Crisis To Car Crash

Even the Chairman of the Federal Reserve sometimes seriously understates reality:

From the IMPO Magazine at: 
http://www.impomag.com/news/2014/01/bernanke-likens-08-financial-crisis-car-crash?et_cid=3715337&et_rid=54744345&type=cta

WASHINGTON (AP) — In his final public appearance as chairman of the Federal Reserve, Ben Bernanke took a moment to reflect on the 2008 financial crisis and compared it to a very bad car crash.

During an interview at the Brookings Institute, he recalls some “very intense periods” during the crisis, similar to trying to keep a car from going over a bridge after a collision. But after some time, he looked back and said, “Oh my God.”

Bernanke admits to some sleepless nights after Lehman Brothers collapsed in September 2008 and triggered the worst financial meltdown since the Great Depression.

Bernanke is stepping down as chairman at the end of the month. He will be replaced by Janet Yellen.

Medical Device Patent Case: Jury Rules Medtronic Willfully Infringed TAVI Heart Valve Patent from Edwards Lifesciences

Smart phones and similar devices have very valuable patents and high-stakes patent litigation.  There are also high stakes in medical devices. Read about this jury verdict below:

Jury Rules Medtronic Willfully Infringed TAVI Heart Valve Patent from Edwards Lifesciences

This story was published in Medical Product Oursourcing (MPO) at:

Part of Heart Valve

http://mpo-mag.com/contents/view_breaking-news/2014-01-16/jury-rules-medtronic-willfully-infringed-heart-valve-patent-from-edwards-lifesciences/#sthash.ZOp8obYx

Medtronic Inc.’s CoreValve system infringes on a patent of Edwards Lifesciences Corp., according to the ruling of a federal court jury in Delaware on Jan. 15. The ruling, part of an ongoing legal battle between the two companies, holds Medtronic liable for $393.6 million in damages.

CoreValve is used in a transcatheter aortic valve implantation (TAVI) procedure, a minimally invasive treatment option for people with severe aortic stenosis. It received CE mark in Europe in 2007, but is not yet available in the United States. Minneapolis, Minn.-based Medtronic expects U.S. Food and Drug Administration approval by the completion of its 2014 fiscal year (end of April). Edwards has had the U.S. aortic valve market to itself since November 2011. Analysts expect TAVI to be a $3 billion worldwide market by the end of the decade.

Edwards and Medtronic are the two largest players in the European market for transcatheter aortic valves. And, perhaps as a result, the companies are no strangers to this sort of court battle. They have battled it out in U.S. and European courts before about patents held by Irvine, Calif.-based Edwards.

The Effect of Congress’ 1998 Extension of Copyright Protection

A colleague pointed me to this very interesting article in the Dec 31, 2013 Washington Post written by Brian Fung.  The article highlights some of the significant differences between the duration of copyright protection versus patent protection. And also points out a number of iconic works that would be in the public domain now except for Congressional extensions of copyright protection.

The title of the article is: “If not for Congress, Superman, Lassie and Scrabble would be free for anyone to reproduce tomorrow”.

After the copyright extensions by Congress in 1998, works before 1978 can have copyright protection for up to 95 years!!

The author points out that:

“On Jan. 1, a whole raft of artistic and intellectual works will be making their way into the public domain — or they would be if Congress hadn’t extended copyright terms for the umpteenth time in 1998. At its core, copyright is meant to protect authors and creators. But as we’ve seen recently with a battle over Sherlock Holmes, copyrights can sometimes prevent well-meaning fans from showing the depth of their appreciation for a work by becoming creators themselves.”

“These days things that were published before 1978 enjoy copyright protections of up to 95 years, but that wasn’t always the case. Under the rules Congress made before the most recent term extension, rights-holders of older works were protected for just 75 years — at which point the work would enter the public domain and be free for anyone to use or riff upon.”

See the full article for more details:

http://www.washingtonpost.com/blogs/the-switch/wp/2013/12/31/if-not-for-congress-superman-lassie-and-scrabble-would-be-free-for-anyone-to-reproduce-tomorrow/?wprss=rss_technology&wpisrc=nl_tech