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Ethicon oct 30
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J&J's Ethicon Partners With Fogarty Institute To Back Next-Gen Device Innovation
Oct 28, 2015 | Fierce Medical Devices
By Stacy Lawrence
Nonprofit incubator Fogarty Institute for Innovation is partnering with Johnson & Johnson's ($JNJ) surgical device specialist Ethicon to develop next generation medical devices. Ethicon will sponsor the Institute to support its educational programs as well as offer leadership and mentorship to its resident med tech innovators. -
Lawsuit: Vaginal Mesh Product Negligently Designed
Oct 30, 2015 | Top Class Actions
By Ashley Vanover
A lawsuit against transvaginal mesh product manufacturer American Medical Systems (AMS) alleges that the company fraudulently concealed the dangers of its devices and is in violation of consumer protection laws. Endo International acquired AMS for about $2.6 billion in April 2011, as the lawsuits over vaginal mesh and bladder... -
Optimism About Synergy Stent Launch Pushes Boston Sci Stock Up 9%, Despite Quarterly Loss
Oct 29, 2015 | Fierce Medical Devices
By Varun Saxena
Boston Scientific ($BSX) said during its Q3 earnings call that it is going to charge a premium for its Synergy drug-eluting stent in the U.S., as it seeks to capitalize on becoming the first company to earn FDA approval for a (partially) bioresorable stent.
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J&J's Ethicon Partners With Fogarty Institute To Back Next-Gen Device Innovation
Oct 28, 2015 | Fierce Medical Devices
By Stacy Lawrence
Nonprofit incubator Fogarty Institute for Innovation is partnering with Johnson & Johnson's ($JNJ) surgical device specialist Ethicon to develop next generation medical devices. Ethicon will sponsor the Institute to support its educational programs as well as offer leadership and mentorship to its resident med tech innovators.
The alignment comes a scant few months after Fogarty did a deal with the U.S. Food & Drug Administration for an educational program on ways to improve its communication with early-stage medical device innovators. That aligns the institute with not only the FDA but also the top med tech R&D spender and revenue generator, Johnson & Johnson.
For its part, J&J recently reiterated a commitment to tapping into innovation via partnerships. In fact, J&J device unit chief medical science and technology officer Bruce Rosengard recently stressed "bidirectional" partnerships in the conglomerate's efforts, such as the deal it did with Google on surgical robotics, in an interview with FierceMedicalDevices.
The Fogarty-Ethicon alignment offers J&J the ability to routinely interact with promising early device innovators, while the incubator gains financial support as well as access and resources for its entrepreneurs. Obviously, both parties are likely hoping this deal will bear further strategic plans--including potential financings, partnerships and deals.
Next year, the pair expect to launch a joint curriculum on medical device development to offer to Fogarty entrepreneurs.
"This is an exciting partnership with Ethicon and an important step towards advancing medical innovation," said Fogarty President and CEO Ann Fyfe in a statement. "Support from world-class med tech leaders like Ethicon provides strong validation of our mission and approach, and we greatly appreciate the expertise they will share with our innovators."
She concluded, "Today, more than ever before, early stage med tech companies are challenged to bring their products to market while facing a tough regulatory and funding environment. … We are looking forward to a long-term partnership."
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Lawsuit: Vaginal Mesh Product Negligently Designed
Oct 30, 2015 | Top Class Actions
By Ashley Vanover
A lawsuit against transvaginal mesh product manufacturer American Medical Systems (AMS) alleges that the company fraudulently concealed the dangers of its devices and is in violation of consumer protection laws.
Endo International acquired AMS for about $2.6 billion in April 2011, as the lawsuits over vaginal mesh and bladder sling products previously sold by the company were beginning to mount. Among products marketed by AMS for transvaginal mesh treatment were the AMS Pedigree, AMS Apogee, and AMS Elevate implants.
The most recent vaginal sling lawsuits filed and joining the AMS MDL come from Mississippi plaintiff Christy C. contends that the MiniArc Sling, a vaginal sling device, implanted surgically in July 2011 was negligently designed, thereby causing serious vaginal mesh complications. Vaginal Mesh Side Effects
Vaginal mesh (also known as pelvic mesh) is a medical device implanted to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). These common, debilitating conditions occur in women who have weakened muscles in the pelvic floor.
When the mesh is implanted (usually transvaginally, through incisions in the vagina) it supports these muscles and prevents organs from descending.
Vaginal mesh is associated with some severe side effects. One of the most common is erosion of the mesh into nearby tissues. Mesh erosion through the vaginal tissue can cause pain, bleeding and infection. The mesh can also perforate or damage internal organs — including the intestines, bladder, blood vessels, nerves, and more.
In 2011, the FDA warned about a previously unidentified risk — contraction of the mesh, which could cause severe pain and vaginal disfigurement. Many vaginal mesh side effects require corrective surgery — but even with surgery, some of the side effects may be permanent.
Vaginal mesh complications may include: Erosion of the mesh into the vaginaOrgan perforationInfectionNerve damageDisfigurement of the vaginaContraction of the meshScarringPelvic painPain during sexual intercourseInability to engage in sexual intercourseDisfigurement of the vaginaEmotional traumaNeed for revision surgeries American Medical Systems MDL
Earlier this year, Endo announced it had reached agreements to settle more than 22,000 AMS vaginal mesh lawsuits for $830 million. However, this agreement still left thousands of vaginal mesh claims unresolved.
In addition to claims involving AMS mesh, more than 50,000 other lawsuits are pending nationwide against manufacturers of similar transvaginal mesh products, including Boston Scientific, C.R. Bard, Coloplast Corp, Cook Medical, Neomedic and Johnson & Johnson subsidiary Ethicon.
While some of the lawsuits are scattered throughout state courts, most of the vaginal mesh litigation is pending in the federal court system, where seven different federal multidistrict litigations (MDLs) have been established before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.
That’s to help reduce duplicative discovery in the cases, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
If you were injured by AMS vaginal sling or other transvaginal mesh device, you may still have time to file a lawsuit and receive compensation for your injuries. Thousands of people have suffered from chronic mesh pain, mesh erosion, infection, organ perforation, revision surgeries, and other serious injuries.
This Vaginal Sling Lawsuit is Civil Action No. 2:15-CV-012949, and the AMS Vaginal Mesh MDL is In re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2325, U.S. District Court, Southern District of West Virginia, Charleston Division.
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Optimism About Synergy Stent Launch Pushes Boston Sci Stock Up 9%, Despite Quarterly Loss
Oct 29, 2015 | Fierce Medical Devices
By Varun Saxena
Boston Scientific ($BSX) said during its Q3 earnings call that it is going to charge a premium for its Synergy drug-eluting stent in the U.S., as it seeks to capitalize on becoming the first company to earn FDA approval for a (partially) bioresorable stent.
The Synergy's polymer coating starts to get absorbed by the body following the completion of the elution of the drug everolimus, which takes three months, but its platinum chromium body and stent struts do not dissolve away from within the coronary artery.
Boston Scientific CEO Michael Mahoney talked about the U.S. product launch extensively, saying, "From a pricing point of view, clearly, many hospitals would desire no price premium. We don't believe that's warranted, based on the acute performance of the stent and also the experience that we've seen in Europe, and we also have a terrific alternative for hospitals with our Promus Premier. So, it's our job to prove the unique benefits of the platform that justify the premium. We've done that in Europe, and that will be our plans as well in the U.S."
He said the device represents more 30% of the company's drug-eluting stent revenue in Europe, and more than half in its top ten markets. Mahoney expects similarly strong results in the U.S., but noted that the devices has "a slower ramp than traditional DES launches, as there's a contracting element to it and it's a premium product."
In addition, Boston Scientific is excited about a post-approval "short DAPT" study, because many patients spontaneously discontinue dual antiplatelet drug therapy, to the concern of the FDA and medical community, said chief medical officer Dr. Keith Dawkins.
Optimism about the Synergy stent helped push Boston Scientific's stock price up 9.3% since the earnings announcement, despite word of a $198 million quarterly loss, compared with a profit of $43 million a year earlier. The company has lost $97 million so far in 2015. Quarterly sales were $1.88 billion, up 2% as reported and 9% when excluding divestitures and exchange rate fluctuations.
The quarterly loss was driven by $457 million in litigation-related charges as a result of an increased transvaginal surgical mesh product liability reserve. "Although the pace of newly filed claims has slowed overtime, our known claim count is now in excess of 30,000 and we now have reached conditional settlement agreements with certain plaintiffs' counsel throughout 2015 to resolve over 6,000 cases and claims. Our total legal reserve, of which mesh is included, was $1.559 billion as of September 30, 2015, and we believe it reflects our best estimate of what is probable and estimable," said Chief Financial Officer Daniel Brennan.
Also of concern to Wall Street is declining growth in the company's cardiac rhythm management franchise of implantable defibrillators and pacemakers; quarterly revenues fell $29 million year-over-year to $451 million. The weakness was particularly apparent in the U.S., while the company said its European unit delivered low to mid-single digit growth.
"The company's outlook for CRM remains tepid, as a poor replacement cycle and competitive launches (mostly from MDT) will hurt into 2016," wrote Jefferies equity analyst Raj Denhoy.
But the main story from the solid earnings call (liability issues aside) is enhanced faith in Boston Scientific's management on Wall Street. Overall, "Boston posted an in-line 3Q in terms of revenues, but the progress on margins was tangible," Denhoy wrote.
"Given the company's recent consistency in delivering EPS (earnings per share) in-line or better than expectations--now 12 consecutive quarters--and an upcoming slew of new product launches across its businesses, we are increasingly confident that BSX can continue to deliver and execute on if not exceed its long-term goals." Leerink's Danielle Antalffy wrote.
Indeed, most Boston Scientific devices had a strong quarter. Structural heart revenue (consisting of the Watchman to prevent stroke and Lotus TAVR) is expected to deliver at the high end of the $75 million to $100 million annual revenue goal the Mahoney said. The company is anticipating publication of a study that will demonstrate that the Watchman can save the healthcare system money over the long-run.
Growth in neuromodulation was also strong at 11% on a constant currency basis, led by the Precision Spectra spinal cord simulation device. "Another big part of our strategy in Neuromod's is expanding beyond pain. We've been investing for a number of years in our deep brain stimulation platform, and I said in my prepared comments, we have a primary sell DBS launch called Vercise that we're really excited about," Mahoney said.
The device recently earned a CE mark to treat Parkinson's disease (PD), primary and secondary dystonia, and essential tremor. The company is enrolling patients in its U.S. clinical trial.
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