FDA OKs TVU as 2nd placement test for Bayer’s Essure

(Reuters) — Bayer (ETR:BAYN) said today that the FDA approved using transvaginal ultrasound as an alternate test to confirm if the company’s Essure permanent birth control device has been placed properly.

Essure is a small metal coil inserted into woman’s fallopian tubes. Since its FDA approval in 2002, women using the device have sent the safety watchdog more than 5,000 complaints, ranging from pain and menstrual problems to pregnancies and even deaths.

Some of the complaints related to the placement of the device.

In a transvaginal ultrasound, sound waves emitted from a probe placed in vagina help a physician check if Essure has been placed properly.

This test is an alternative to the generally-prescribed modified hysterosalpingogram test in which an X-ray of the uterus and fallopian tubes is used to check for proper device placement.

Women using Essure must do a test to confirm that the device is properly placed within 3 months of the procedure, using alternate birth control methods confirmation from a doctor, Bayer said today.

All physicians who offer Essure are expected to be trained to perform the TVU confirmation test by mid-2016, the company said.

The training will start in September, the same month the FDA is slated to hold a public panel meeting to discuss the safety and effectiveness of Essure.

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CMS Open Payments: Top medical device spenders

Forty medical device companies paid out a collective $872.3 million to hospitals and doctors last year, including $652.7 million in general payments and $219.6 million in research grants, according to the Open Payments database compiled by the Centers for Medicare & Medicaid Service.

The Open Payments program, created under the Affordable Care Act with the aim of improving transparency, requires device and drug manufacturers to report payments to healthcare providers for things like speaking engagements about their products and research grants. General payments can include such costs as travel and lodging and food and beverages.

The report, in its 2nd year, lists 11.4 million payments to 607,000 physicians and more than 1,100 teaching hospitals made by 1,444 companies. U.S. doctors and research hospitals collected nearly $6.5 billion in payments for services rendered to medical device and pharmaceutical companies in 2014

Not surprisingly, the world’s largest medtech makers topped the list of medical device companies. Medtronic (NYSE:MDT) reported dropping $133.4 million in general payments and another $56.5 million in research grants, for a total of $189.9 million (21.8% of the total for the 40 companies). Johnson & Johnson (NYSE:JNJ) said it paid out $102.6 million to docs and hospitals and $32.5 million in research grants, for a total of $135.0 million or 15.5% of the total. Third up was Stryker (NYSE:SYK), reporting general payments of $73.1 million and research grants of $5.7 million, for a total of $78.8 million or 9.0% of the total.

Here’s a look at how the payments broke down for 40 of the largest medical device makers:

Company	General	Research	Total
Medtronic	$133,435,541	$56,505,542	$189,941,083
Johnson & Johnson	$102,557,688	$32,459,001	$135,016,690
Stryker	$73,135,901	$5,689,436	$78,825,337
Zimmer	$50,781,224	$2,945,652	$53,726,876
St. Jude Medical	$46,314,531	$7,293,312	$53,607,843
Edwards Lifesciences	$6,846,746	$44,028,352	$50,875,097
Boston Scientific	$26,269,132	$18,405,660	$44,674,792
Smith & Nephew	$41,802,547	$2,462,420	$44,264,967
Intuitive Surgical	$29,107,086	$377,273	$29,484,359
Alcon (Novartis)	$20,794,876	$3,438,723	$24,233,599
Abbott	$11,892,686	$12,272,052	$24,164,738
NuVasive	$22,175,132	$484,018	$22,659,150
Bayer HealthCare	$10,950,400	$11,174,438	$22,124,838
Baxter	$6,989,791	$6,224,416	$13,214,207
Siemens Healthcare	$11,397,626	$1,492,400	$12,890,027
Wright Medical	$12,092,697	$108,085	$12,200,782
GE Healthcare	$5,749,565	$4,630,828	$10,380,393
B. Braun	$6,361,682	$1,021,123	$7,382,805
C.R. Bard	$6,549,118	$775,866	$7,324,984
Philips Electronics North America	$3,975,923	$2,134,861	$6,110,784
Olympus	$4,596,710	$1,273,247	$5,869,957
Orthofix	$4,093,068	$398,724	$4,491,792
HeartWare	$1,561,116	$1,664,084	$3,225,200
Fujifilm	$2,455,951	$104,837	$2,560,789
Masimo	$2,433,149	n/a	$2,433,149
Thoratec	$1,161,293	$198,195	$1,359,488
3M	$1,256,137	$103,195	$1,359,332
Fresenius	$613,005	$449,368	$1,062,373
Getinge (Maquet)	$1,004,645	$31,790	$1,036,434
Toshiba Medical	$619,766	$401,163	$1,020,929
Cardinal Health	$961,630	n/a	$961,630
Terumo	$616,991	$156,302	$773,293
Accuray	$252,499	$336,817	$589,316
NxStage Medical	$461,153	$82,360	$543,513
Insulet	$528,430	n/a	$528,430
Arthrocare	$418,620	$35,389	$454,009
ResMed	$99,271	$319,076	$418,346
Greatbatch	$213,018	n/a	$213,018
Beckman Coulter (Danaher)	$102,271	$100,000	$202,271
Hitachi	$70,436	n/a	$70,436

Material from Reuters was used in this report.

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Sanuwave updates on PMA trial for Dermapace

Sanuwave Health (OTC:SNWV) said yesterday it met with the FDA to discuss the progress of a pre-market approval trial of its Dermapace diabetic foot ulcer treatment.

The 130-patient study completed enrollment in November last year and each patient has completed a full-24-week follow-up, the Alpharetta, Ga.-based company said.

Sanuwave said it is completing an audit of the clinical documentation of each study site, which will be followed by a final review and locking of the study database. After the lock the data can be analyzed, and checked to see if the trial met primary endpoints, the company said.

“We are very pleased to have reached this major milestone in the supplemental clinical trial of Dermapace to treat diabetic foot ulcers. The positive feedback from the FDA at our meeting to discuss the Dermapace clinical study gives us the confidence to stop further enrollment in the study and move towards final data review and PMA submission to the FDA,” chairman Kevin Richardson II said in a press release.

Last month, Sanuwave said the oversight board for the clinical trial of its DermaPace wanted more data after determining that the trial was unlikely to meet its primary endpoint.

An interim analysis by the trial’s independent Data Monitoring Committee found that if the trend holds the endpoint “will likely not be met at the next predefined analysis point of 170 patients,” the company said.

After meeting with the FDA, Sanuwave said the federal watchdog was on-board with a new “plan to analyze additional secondary objectives,” and that “there is precedence of FDA approving devices via PMA based on the totality of the data,” according to a Sanuwave conference call.

“What this means is that, even failing to achieve a primary objective, if other data, including secondary endpoints, shows a clinically meaningful outcome, the FDA can still make an “approvable” decision,” veep of operations and regulatory affairs Pete Stegagno said in the conference call.

“With the recent positive feedback from the FDA, we have now begun discussions with various strategic parties about partnering on the commercialization of the product. The Dermapace, with its novel biologic regenerative effects, holds promise to heal diabetic foot ulcers and increase limb preservation, thus improving quality of life for these patients and their families and significantly easing the economic burden on an overwhelmed healthcare system that cares for these patients. We are moving quickly toward our ultimate goal of obtaining FDA approval for Dermapace and commercializing the technology in the U.S. where millions of people suffer from costly and debilitating diabetic foot ulcers,” Richardson said in prepared remarks.

Back in 2011 the FDA sent Sanuwave a “major deficiency” letter and asked the company to run another trial for DermaPace, an extra-corporeal shock wave technology. The company launched the 2nd trial more than 3 years ago.

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DJO Global closes Zimmer/Biomet buys

DJO Global said yesterday its subsidiary Encore Medical has closed on the purchase of Zimmer (NYSE:ZMH) and Biomet assets that the merging companies were unloading to satisfy U.S. anti-trust regulations.

The purchase included Biomet Cobalt bone cement, Optivac cement mixing accessories, the SoftPac pouch and Discovery elbow system for the U.S. marketplace, DJO Global said.

Financial details of the acquisitions were not disclosed, the San Diego, Calif.-based company said.

“These product acquisitions are a part of a broader strategy to invest in our fast growing implant business. We believe our surgical division is poised to continue its position as the fastest growing orthopedic implant company. I have always admired Cobalt bone cement’s color features which offer better visualization and much simpler packaging and the Discovery elbow is extremely well-regarded,” CEO Mike Mogul said last week in a press release.

“This acquisition is very timely for us based on our disruptive entrance into the revision market with our Exprt Revision knee launched at AAOS this year and the Discovery elbow provides great breadth to our strong upper extremity portfolio. With 3 major launches planned across the knee, hip and shoulder segments in each of the next 3 years, we are excited about our continued opportunities for growth,” president Brady Shirley said in a prepared statement.

The purchase was announced last week as Zimmer and Biomet closed their $14 billion merger. The merged companies also sold their U.S. unicompartmental High Flex knee assets to Smith & Nephew.

In April Zimmer agreed to sell the High Flex and Discovery assets in the European Economic Area and Switzerland and Biomet’s Vanguard complete knee system in Denmark and Sweden to Lima Corporate SpA. European anti-trust regulators OKed the deal in late March.

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CMS Open Payments: Device, drug makers drop $6.5m on hospitals, docs

(Reuters) — U.S. doctors and research hospitals collected nearly $6.5 billion in payments for services rendered to medical device and pharmaceutical companies in 2014, according to the Centers for Medicare & Medicaid Services Open Payments report released yesterday.

The report, in its 2nd year, lists 11.4 million payments to 607,000 physicians and more than 1,100 teaching hospitals made by 1,444 companies.

The Open Payments program, which was created under the Affordable Care Act with the aim of improving transparency, requires device and drug manufacturers to report payments to healthcare providers for things like speaking engagements about their products and research grants.

The report allows individuals to track payments to their physicians by drug companies. The need for greater transparency was spawned by concerns that physician prescribing habits and choices could be driven by payments from pharmaceutical and medical device companies.

Among medical device makers, Boston Scientific (NYSE:BSX) spent more in general payments than for research fees, reporting $18.4 million in research payments and $26.3 million in general payments, while Edwards Lifesciences (NYSE:EW) spent $44 million in research payments and $6.8 million in general payments.

Pfizer (NYSE:PFE), the largest U.S. drugmaker, for example reported more than $234.2 million in research payments and another $53.3 million in general payments.

Dr. John Diliberti, a pediatric geneticist from Illinois, collected nearly $447,000 from Pfizer in consulting fees last year, the biggest single payment to an individual doctor by the drugmaker.

Britain based drugmaker GlaxoSmithKline (NYSE:GSK) reported $177.1 million in research payments and another $36 million in general payments.

General payments can include such costs as travel and lodging and food and beverages.

Amgen (NSDQ:AMGN), the world’s largest biotechnology company, spent about $117 million in research payments and $23 million in general payments, including expenditures by its Onyx Pharmaceuticals unit.

Its single highest payment to an individual of $282,336 went to Michigan genetics expert Gilbert Omenn.

MD Anderson Cancer Center, widely considered to be the nation’s top cancer research facility, collected $92.7 million in research payments along with $12.4 million in general payments. Its largest payment of more than $2.9 million in royalty or license fees came from medical equipment maker Siemens Medical Solutions (NYSE:SI).

Cleveland Clinic, the top-rated cardiac care hospital, collected $25.1 million in research payments and $12.9 million in general payments. Its largest payment of $1.2 million also came from Siemens, followed by $941,311 from biotech Biogen Idec (NSDQ:BIIB).

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ConforMIS prices $135m IPO

ConforMIS yesterday priced its initial public offering at $15 per share, for total proceeds of $135 million.

The 9-million-share IPO also includes a 1.35-million underwriters over-allotment option, Bedford, Mass.-based ConforMIS said.

Earlier this month the company set the terms for its forthcoming initial public offering, saying it plans to float 9 million shares at $14 to $16 apiece.

Bedford, Mass.-based ConforMIS said last month that the IPO could bring in as much as $172.5 million.

The company plans to trade on the NASDAQ exchange today under the “CFMS” symbol. The company originally filed confidentially March 20, according to the SEC.

The company plans to file for FDA approval of its customized hip implant this year, according to a regulatory filing.

“We expect to submit an application for clearance of iTotal Hip, our 1st customized hip replacement implant, to the U.S. Food & Drug Administration, or FDA, in 2015,” ConforMIS said.

J.P. Morgan and Deutsche Bank are the joint bookrunners on the IPO, with Wells Fargo Securities, Canaccord Genuity and Oppenheimer & Co. acting as co-managers.

ConforMIS said it employs 86 sales reps in the U.S., Germany and the U.K. The company reported sales of $48.2 million last year, a 39% increase over 2013, and said 1st-quarter revenues were $14.7 million, up 36% over Q1 2014.

Last month ConforMIS and Wright Medical (NSDQ:WMGI) buried the hatchet in a patent infringement dispute over customized instrumentation technology.

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US FDA addresses UDI direct marking for reprocessed devices

By Stewart Eisenhart, Emergo Group

New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse.

The agency’s guidance points out that its UDI rule, 21 CFR 801.25, explicitly requires directing UDI marking on devices to be reused and reprocessed before each use; however, the rule does not define the terms “intended to be used more than once” or “reprocessed,” prompting questions about adequate compliance.

To clarify this issue, the FDA has issued the new guidance to seek industry input on two key questions:

• Should the definition of “reprocessing” in relation to direct UDI marking requirements cover device cleaning without additional disinfection and/or sterilization? (Separate FDA guidance states that device reprocessing should include three steps: point-of-use processing, cleaning and disinfection and/or sterilization.)
• What public health benefits would be realized by requiring direct UDI marking of devices for which reprocessing instructions pertain only to cleaning, not disinfection or sterilization?

The FDA has posited that UDI marking directly on medical devices designed for reuse and reprocessing is necessary because such devices are eventually separated from their original labeling and packaging.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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