Medical Devices Today

Medtronic, Covidien, Other Stock Held By Judges In Health-Care Reform Suits

Boston Scientific Gets $400,000 Tax Break For Massachusetts Expansion
Medtronic’s $7 Million In Royalties To Kentucky Surgeon Invites Scrutiny
St. Jude Withdraws Riata Defibrillator Cables From Market Over Insulation Issues
Medtronic Atrial Fibrillation Freezing Device Gets FDA Approval
GE Healthcare Acquires 84 Percent Stake In Clarient, Intends To Buy Rest
J&J, DePuy Artificial Hip Fails In Patients At Unusually High Rate
Boston Scientific’s Guidant Gains Federal Foe In False Claims Act Suit
Stryker Sues Zimmer For Alleged Infringement Of Wound-Treatment Patents
Abbott Sales Reps Allowed To View Surgery To Implant Stents, Doctor Says
Medtronic Mulls Change In Testing Devices To Meet Critics’ Concerns
J&J Sets Up Competition Among Drug, Devices Heads To Be Overall Chief
Guidant Wins As U.S. Supreme Court Declines Review Of Endograft Suit

Continuous Glucose Monitoring: A Case Study for Commercializing Products In The Era of Patient-Driven Health Care

Article preview from IN VIVO- November 01, 2010

Continuous glucose monitoring for patients with diabetes presents an example of how an individual product has far less value than the integrated solution the technology enables. While continuous glucose monitoring offers significant value to a broad range of patients, the technology has still not fulfilled its market potential. Factors hindering more widespread adoption include inaccuracy, difficulty in using the systems, and low levels of patient adherence. But the greatest obstacle in CGM is the disconnect between CGM and treatment planning; CGM produces mounds of data that patients and even physicians don't know how to use. According to Health Care Advances, if this powerful dataset is optimized, shared, and applied, it could shift CGM from a niche product for a small number of type 1 diabetes patients into a standard of care for many metabolic diseases.

Arineta Ltd.

Article preview from Start Up- November 01, 2010

Instead of relying on a conventional whole-body computed tomography scan in a hospital setting for cardiac imaging, cardiologists could someday have a smaller, lighter and less expensive CT system in their own office. Israeli-based Arineta Ltd. is developing just such a dedicated cardiovascular CT device.

TCT 2010: TAVI Takes Center Stage

Article preview from Medtech Insight- December 01, 2010

In the interventional cardiology community, 2010 could certainly be considered a breakthrough year for percutaneous heart valve devices. At two major US cardiology conferences: the American College of Cardiology in the spring, and most recently, the Transcatheter Cardiovascular Therapeutics symposium, held in September, impressive results from randomized trials of transcatheter heart valve replacement/repair devices set the venues abuzz and had physicians speculating about possible near-term paradigm shifts in the way heart valve disease will be treated. The big questions now are how long it will take before these devices reach the US market, and exactly how many US patients are likely to be implanted once they are available.

A Question For Parallel Review Planners: When CMS Should Get Involved

Article preview from "The Gray Sheet" - December 20, 2010

As FDA and CMS officials develop steps for parallel medical product reviews, a key question is when CMS should be brought into the pre-market process.

Thermo Fisher To Acquire Chromatography Maker Dionex For $2.1 Billion

Boston Scientific Considers Dropping Proposed Sale Of Neuromodulation Unit
Medtronic Gets FDA Approval For Software To Monitor Diabetes Treatment
Edwards Lifesciences Expects U.S. Launch Of Sapien Heart Valve Within Year
C.R. Bard To Cut Jobs Globally As Part Of Restructuring, Cost-Cutting Plans
Biomet Said Ready To Bid Cash To Buy Smith & Nephew, But Doubts Raised
VNUS Unit Of Covidien Awarded $45.8 Million In TVS, Biolitec Patent Suit
Beckman Coulter Said Weighing Investor Offer To Buy, Take It Private
Half Of Medtronic Patients With Sprint Fidelis Left Without Damage Recourse
Medtronic Served With Federal Subpoena Over Neurostimulation Devices
Medtronic Gains EU Approval For CoreValve’s Heart-Valve Replacement
Abbott, Boston Sci, Medtronic Lead In Using iPads To Promote Devices

Advancing Ablative Tumor Therapies Into Primary Treatments

Article preview from Start Up- November 01, 2010

For many cancers, there is a need for a third option between the two current choices of radical tissue destruction and watchful waiting. New cancer ablation devices in development have the potential to fill that gap. Ablative tumor therapies can play a role in eradication of early-stage and localized tumors, as salvage therapies in patients who've failed other therapies, and for patients whose health precludes surgery or further radiation. Ablation has many advantages. It's a cost-effective and minimally invasive alternative to robotic surgery or radiation devices, and may lead to fewer side effects and complications than current primary tumor treatments. But proving that ablation can save lives compared to more radical forms of therapy requires clinical evidence from multiyear outcome trials that few smaller companies are willing to invest in. There's little evidence to date that venture investors will see returns. But the race is on among companies hoping to become the first device approved for low-risk, localized prostate cancer, a potentially game-changing event.

Edwards: Transcatheter Valve Leader Proves You Can Go Home Again

Article preview from In-Vivo- November 01, 2010

After exploring a number of new product markets to drive growth in the decade since its spin-off from Baxter, Edwards has found its sweet spot in its own backyard: heart valves. Through an aggressive early acquisition, the company has emerged as the leader in what looks to be the next major device product market: - transcatheter valves. But in building a transcatheter valve business, Edwards must maintain its surgical customers while also selling to new physician customers: interventionalist cardiologists - a clinical specialty with a history of competing with surgery.

Deals Update

Article preview from Medtech Insight- October 01, 2010

A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.

New-Tech "Grace Period" Among Industry Recommendations For ACOs

Article preview from "The Gray Sheet" -  December 13, 2010

AdvaMed says it wants CMS to permit at least a five-year grace period from accountable care organization payment rules for physician early adopters of new medical technologies and treatments.